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draft, or money order payable to the 381.14 Inspection concerning purportedly ex- Treasurer of the United States and empted operations. shall be remitted promptly to the Ad- 381.15 Exemption from definition of ‘‘poul- ministrator upon furnishing to the ap- try product’’ of certain human food products containing poultry. plicant a statement as to the amount due. Subpart D—Application for Inspection; (c) The fees to be charged and col- Grant or Refusal of Inspection lected for service under the regulations in this part shall be at the rates speci- 381.16 How application shall be made. fied in §§ 391.2, 391.3, and 391.4 respec- 381.17 Filing of application. tively for base time; for overtime in- 381.18 Authority of applicant. cluding Saturdays, Sundays, and holi- 381.20 Survey and grant of inspection. 381.21 Refusal of inspection. days; and for certain laboratory serv- 381.22 Conditions for receiving inspection. ices which are not covered under the base time, overtime, and/or holiday Subpart E—Inauguration of Inspection; Of- costs. Such fees shall cover the costs of ficial Establishment Numbers; Separa- the services and shall be charged for tion of Establishments and Other Re- the time required to render such serv- quirements; Withdrawal of Inspection ice, including, but not limited to, the time required for the travel of the in- 381.25 Official establishment numbers. spector or inspectors in connection 381.26 Separation of establishments. therewith during the regularly sched- 381.27 Inauguration of service; notification concerning regulations; status of uled administrative workweek. uninspected poultry products. (d) Charges may also be made to 381.28 Report of violations. cover the cost of travel and other expenses incurred by the Service in con- Subpart F—Assignment and Authorities of nection with the furnishing of the serv- Program Employees; Appeals ice. 381.30–381.31 [Reserved] [41 FR 23715, June 11, 1976, as amended at 53 381.32 Access to establishments. FR 13398, Apr. 22, 1988; 54 FR 6390, Feb. 10, 381.33 Identification. 1989] 381.34 Financial interest of inspectors. 381.35 Appeal inspections; how made. PART 381—POULTRY PRODUCTS Subpart G—Facilities for Inspection; Over- INSPECTION REGULATIONS time and Holiday Service; Billing Es- tablishments Subpart A—Definitions 381.36 Facilities required. Sec. 381.37 Schedule of operations. 381.1 Definitions. 381.38 Overtime and holiday inspection service. Subpart B—Administration; Application of 381.39 Basis of billing for overtime and holi- Inspection and Other Requirements day services.

381.3 Administration. Subpart H—Attestation on Work-Related 381.4 Inspection in accordance with methods Conditions prescribed or approved. 381.5 Publications. 381.45 Attestation requirements. 381.6 Establishments requiring inspection. 381.46 Severability. 381.7 Coverage of all poultry and poultry products processed in official establish- Subpart I—Operating Procedures ments. 381.65 Operations and procedures, generally. Subpart C—Exemptions 381.66 Temperatures and chilling and freezing procedures. 381.10 Exemptions for specified operations. 381.67 Young chicken and squab slaughter 381.11 Exemptions based on religious die- inspection rate maximums under tradi- tary laws. tional inspection procedure. 381.12 Effect of religious dietary laws ex- 381.68 Maximum inspection rates—New tur- emptions on other persons. key inspection system. 381.13 Suspension or termination of exemp- 381.69 Maximum line speed rates under the tions. New Poultry Inspection System.

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Subpart J—Ante Mortem Inspection 381.103 Official poultry condemnation certificates; issuance and form. 381.70 Ante mortem inspection; when re- 381.104 Official export certificates, marks quired; extent. and devices. 381.71 Condemnation on ante mortem in- 381.105 Export certification; marking of spection. containers. 381.72 Segregation of suspects on ante 381.106 Form of official export certificate. mortem inspection. 381.73 Quarantine of diseased poultry. 381.107 Special procedures as to certifi- 381.74 Poultry suspected of having biologi- cation of poultry products for export to cal residues. certain countries. 381.75 Poultry used for research. 381.108 Official poultry inspection certificates; issuance and disposition. Subpart K—Post Mortem Inspection; 381.109 Form of official poultry inspection Disposition of Carcasses and Parts certificate. 381.110 Erasures or alterations made on cer- 381.76 Post-mortem inspection under Tradi- tificates. tional Inspection, the Streamlined In- 381.111 Data to be entered in proper spaces. spection System (SIS), the New Line 381.112 Official mark for maintaining the Speed (NELS) Inspection System, the identity and integrity of samples. New Poultry Inspection System (NPIS), the New Turkey Inspection System Subpart N—Labeling and Containers (NTI), and Ratite Inspection. 381.77 Carcasses held for further examina- 381.115 Containers of inspected and passed tion. poultry products required to be labeled. 381.78 Condemnation of carcasses and parts: 381.116 Wording on labels of immediate con- separation of poultry suspected of containers. taining biological residues. 381.117 Name of product and other labeling. 381.79 Passing of carcasses and parts. 381.80 General; biological residues. 381.118 Ingredients statement. 381.81 Tuberculosis. 381.119 Declaration of artificial flavoring or 381.82 Diseases of the leukosis complex. coloring. 381.83 Septicemia or toxemia. 381.120 Antioxidants; chemical preserva- 381.84 Airsacculitis. tives; and other additives. 381.85 Special diseases. 381.121 Quantity of contents. 381.86 Inflammatory processes. 381.121a–381.121e [Reserved] 381.87 Tumors. 381.122 Identification of manufacturer, 381.88 Parasites. packer or distributor. 381.89 Bruises. 381.123 Official inspection mark; official es- 381.90 Cadavers. tablishment number. 381.91 Contamination. 381.124 Dietary food claims. 381.92 Overscald. 381.125 Special handling label requirements. 381.93 Decomposition. 381.94 Contamination with microorganisms; 381.126 Date of packing and date of proc- process control verification criteria and essing; contents of cans. testing; pathogen reduction standards for 381.127 Wording on labels of shipping con- establishments that slaughter ratites. tainers. 381.128 Labels in foreign languages. Subpart L—Handling and Disposal of Con- 381.129 False or misleading labeling or condemned or Other Inedible Products at tainers. Official Establishments 381.130 False or misleading labeling or containers; orders to withhold from use. 381.95 Disposal of condemned poultry prod- 381.131 Preparation of labeling or other de- ucts. vices bearing official inspection marks without advance approval prohibited; ex- Subpart M—Official Marks, Devices and ceptions. Certificates; Export Certificates; Certifi- 381.132–381.133 [Reserved] cation Procedures 381.134 Requirement of formulas. 381.136 Affixing of official identification. 381.96 Wording and form of the official inspection legend. 381.137 Evidence of labeling and devices ap- 381.97 [Reserved] proval. 381.98 Official seal. 381.138 Unauthorized use or disposition of 381.99 Official retention and rejection tags. approved labeling or devices. 381.100 Official detention tag. 381.139 Removal of official identifications. 381.101 Official U.S. Condemned mark. 381.140 Relabeling poultry products. 381.102 [Reserved] 381.141–381.143 [Reserved]

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381.144 Packaging materials. 381.180 Information and reports required from official establishment operators. Subpart O—Entry of Articles Into Official Es- 381.181 Reports by consignees of allegedly tablishments; Processing Inspection adulterated or misbranded products; sale and Other Reinspections; Processing or transportation as violations. Requirements 381.182 Reports of inspection work. 381.146 Sampling at official establishments. Subpart R—Cooperation With States and 381.148 Processing and handling require- Territories; Certification of State and ments for frozen poultry products. Territorial Programs as at Least Equal 381.150 Requirements for the production of to Federal Program fully cooked poultry products and partially cooked poultry breakfast strips. 381.185 Assistance to State and Territorial 381.151 Adulteration of product by polluted programs. water; procedure for handling. 381.186 Cooperation of States and other ju- 381.152 Preparation in an official establish- risdictions in Federal programs. ment of articles not for human food. 381.187 Cooperation of States for the inter- 381.153 [Reserved] state shipment of poultry products.

Subpart P—Definitions and Standards of Subpart S—Transportation; Exportation; or Identity or Composition Sale of Poultry or Poultry Products 381.155 General. 381.189 Provisions inapplicable to specimens 381.156 Poultry meat content standards for for laboratory examination, etc., or to certain poultry products. naturally inedible articles. 381.157 Canned boned poultry and baby or 381.190 Transactions in slaughtered poultry geriatric food. and other poultry products restricted; 381.158 Poultry dinners (frozen) and pies. vehicle sanitation requirements. 381.159 Poultry rolls. 381.191 Distribution of inspected products to 381.160 (Kind) burgers; (Kind) patties. small lot buyers. 381.161 ‘‘(Kind) A La Kiev.’’ 381.192 Penalties inapplicable to carriers. 381.162 ‘‘(Kind) steak or fillet.’’ 381.193 Poultry carcasses, etc., not intended 381.163 ‘‘(Kind) baked’’ or ‘‘(Kind) roasted.’’ for human food. 381.164 ‘‘(Kind) barbecued.’’ 381.194 Transportation and other trans- 381.165 ‘‘(Kind) barbecued prepared with actions concerning dead, dying, disabled, moist heat.’’ or diseased poultry, and parts of car- 381.166 Breaded products. casses of poultry that died otherwise 381.167 Other poultry dishes and specialty than by slaughter. items. 381.168 Maximum percent of skin in certain Subpart T—Imported Poultry Products poultry products. 381.169 Ready-to-cook poultry products to 381.195 Definitions; requirements for impor- which solutions are added. tation into the United States. 381.170 Standards for kinds and classes, and 381.196 Eligibility of foreign countries for for cuts of raw poultry. importation of poultry products into the 381.171 Definition and standard for ‘‘Turkey United States. Ham.’’ 381.197 Foreign inspection certificate re- 381.172 Requirements for substitute stand- quirements. ardized poultry products named by use of 381.198 Import inspection application. an expressed nutrient content claim and 381.199 Inspection of poultry products of- a standardized term. fered for entry. 381.173 Mechanically Separated (Kind of 381.200 Poultry products offered for entry, Poultry). retention in customs custody; delivery 381.174 Limitations with respect to use of under bond; movement prior to inspec- Mechanically Separated (Kind of Poul- tion; handling; facilities and assistance. try). 381.201 Means of conveyance and equipment used in handling poultry products offered Subpart Q—Records, Registration, and for entry to be maintained in sanitary Reports condition. 381.202 Poultry products offered for entry; 381.175 Records required to be kept. reporting of findings to customs; han- 381.176 Place of maintenance of records. dling of articles refused entry; appeals, 381.177 Record retention period. how made; denaturing procedures. 381.178 Access to and inspection of records, 381.203 Products offered for entry; charges facilities and inventory; copying and for storage, cartage, and labor with re- sampling. spect to products which are refused 381.179 Registration. entry.

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381.204 Marking of poultry products offered Subpart X—Canning and Canned Products for entry; official import inspection marks and devices. 381.300 Definitions. 381.205 Labeling of immediate containers of 381.301 Containers and closures. poultry products offered for entry. 381.302 Thermal processing. 381.206 Labeling of shipping containers of 381.303 Critical factors and the application poultry products offered for entry. of the process schedule. 381.207 Small importations for consignee’s 381.304 Operations in the thermal processing personal use, display, or laboratory anal- area. ysis. 381.305 Equipment and procedures for heat 381.208 Poultry products offered for entry processing systems. and entered to be handled and trans- 381.306 Processing and production records. ported as domestic; entry into official es- 381.307 Record review and maintenance. tablishments; transportation. 381.308 Deviations in processing. 381.209 Returned United States inspected 381.309 Finished product inspection. and marked poultry products: exemption. 381.310 Personnel and training. Subpart U—Detention; Seizure and 381.311 Recall procedure. Condemnation; Criminal Offenses Subpart Y—Nutrition Labeling 381.210 Poultry and other articles subject to administrative detention. 381.400 Nutrition labeling of poultry prod- 381.211 Method of detention; form of deten- ucts. tion tag. 381.401 Required nutrition labeling of 381.212 Notification of detention to the ground or chopped poultry products. owner of the poultry or other article, or 381.402 Location of nutrition information. the owner’s agent, and person having 381.403–381.407 [Reserved] custody. 381.408 Labeling of poultry products with 381.213 Notification of governmental au- number of servings. thorities having jurisdiction over article 381.409 Nutrition label content. detained; form of written notification. 381.410–381.411 [Reserved] 381.214 Movement of poultry or other article 381.412 Reference amounts customarily con- detained; removal of official marks. sumed per eating occasion. 381.215 Poultry or other articles subject to 381.413 Nutrient content claims; general judicial seizure and condemnation. principles. 381.216 Procedure for judicial seizure, con- 381.414–381.443 [Reserved] demnation, and disposition. 381.444 Identification of major cuts of poul- 381.217 Authority for condemnation or sei- try products. zure under other provisions of law. 381.445 Nutrition labeling of single-ingre- 381.218 Criminal offenses. dient, raw poultry products that are not Subpart V—Special Provisions for Des- ground or chopped products described in § 381.401. ignated States and Territories; Criteria 381.446–381.453 [Reserved] and Procedure for Designating Estab- 381.454 Nutrient content claims for ‘‘good lishments With Operations Which source,’’ ‘‘high,’’ and ‘‘more’’. Would Clearly Endanger the Public 381.455 [Reserved] Health; Disposition of Poultry Products 381.456 Nutrient content claims for ‘‘light’’ Therein or ‘‘lite’’. 381.457–381.459 [Reserved] 381.220 Definition of ‘‘State’’. 381.460 Nutrient content claims for calorie 381.221 Designation of States under para- content. graph 5(c) of the Act. 381.461 Nutrient content claims for the so- 381.222 States designated under paragraph dium content. 5(c) of the Act; application of regula- 381.462 Nutrient content claims for fat, tions. fatty acids, and cholesterol content. 381.223 Control and disposition of nonfederally inspected poultry products in States 381.463 Nutrient content claims for designated under paragraph 5(c) of the ‘‘healthy.’’ Act. 381.464–381.468 [Reserved] 381.224 Designation of States under section 381.469 Labeling applications for nutrient 11 of the Act; application of sections of content claims. the Act and the regulations. 381.470–381.479 [Reserved] 381.225 Criteria and procedure for desig- 381.480 Label statements relating to useful- nating establishments with operations ness in reducing or maintaining body which would clearly endanger the public weight. health; disposition of poultry products 381.481–381.499 [Reserved] therein. 421

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381.500 Exemption from nutrition labeling. considered adulterated under this clause if the quantity of such sub- Subpart Z—Selected Establishments; Coop- stance in or on such article does not erative Program for Interstate Shipment ordinarily render it injurious to health; of Poultry Products (ii)(a) If it bears or contains (by rea- 381.511 Definitions. son of administration of any substance 381.512 Purpose. to the live poultry or otherwise) any 381.513 Requirements for establishments; in- added poisonous or added deleterious eligible establishments. substance (other than one which is a 381.514 State request for cooperative agree- pesticide chemical in or on a raw agri- ment. 381.515 Establishment selection; official cultural commodity; a food additive; or number for selected establishments. a color additive) which may, in the 381.516 Commencement of a cooperative judgment of the Administrator, make interstate shipment program; inspection such article unfit for human food; by designated personnel and official (b) If it is, in whole or part, a raw ag- mark. ricultural commodity and such com- 381.517 Federal oversight of a cooperative interstate shipment program. modity bears or contains a pesticide 381.518 Quarterly reports. chemical which is unsafe within the 381.519 Enforcement authority. meaning of section 408 of the Federal 381.520 Deselection of ineligible establish- Food, Drug, and Cosmetic Act; ments. (c) If it bears or contains any food ad- 381.521 Transition to official establishment. ditive which is unsafe within the mean- 381.522 Transition grants. 381.523 Separation of operations. ing of section 409 of the Federal Food, 381.524 Voluntary withdrawal. Drug, and Cosmetic Act; (d) If it bears or contains any color AUTHORITY: 7 U.S.C. 138f, 450; 21 U.S.C. 451– 470; 7 CFR 2.7, 2.18, 2.53. additive which is unsafe within the meaning of section 706 of the Federal SOURCE: 37 FR 9706, May 16, 1972, unless Food, Drug, and Cosmetic Act: otherwise noted. Provided, That an article which is not Subpart A—Definitions otherwise deemed adulterated under paragraphs (b)(4)(ii) (b), (c), or (d) of § 381.1 Definitions. this section shall nevertheless be deemed adulterated if use of the pes- (a) For the purposes of the regula- ticide chemical, food additive, or color tions in this part, unless otherwise re- additive in or on such article is prohib- quired by the context, the singular ited by the regulations in this part in form shall also import the plural and official establishments; the masculine form shall also import the feminine, and vice versa. (iii) If it consists in whole or in part (b) For the purposes of such regula- of any filthy, putrid, or decomposed tions, unless otherwise required by the substance or is for any other reason context, the following terms shall be unsound, unhealthful, unwholesome, or construed, respectively, to mean: otherwise unfit for human food; Acceptable. ‘‘Acceptable’’ means suit- (iv) If it has been prepared, packed, able for the purpose intended and ac- or held under insanitary conditions ceptable to the Administrator. whereby it may have become contami- Act. ‘‘Act’’ means the Poultry Prod- nated with filth, or whereby it may ucts Inspection Act (71 Stat. 441, as have been rendered injurious to health; amended by the Wholesome Poultry (v) If it is, in whole or in part, the Products Act, 82 Stat. 791; 21 U.S.C. 451 product of any poultry which has died et seq.). otherwise than by slaughter; Adulterated. ‘‘Adulterated’’ applies to (vi) If its container is composed, in any poultry product under one or more whole or in part, of any poisonous or of the following circumstances: deleterious substance which may (i) If it bears or contains any poi- render the contents injurious to sonous or deleterious substance which health; may render it injurious to health; but (vii) If it has been intentionally sub- in case the substance is not an added jected to radiation, unless the use of substance, such article shall not be the radiation was in conformity with a

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regulation or exemption in effect pur- Commerce. ‘‘Commerce’’ means com- suant to section 409 of the Federal merce between any State, any terri- Food, Drug, and Cosmetic Act; or tory, or the District of Columbia, and (viii) If any valuable constituent has any place outside thereof; or within been in whole or in part omitted or ab- any territory not organized with a leg- stracted therefrom; or if any substance islative body, or the District of Colum- has been substituted, wholly or in part bia. therefor; or if damage or inferiority Consumer package. ‘‘Consumer pack- has been concealed in any manner; or if age’’ means any container in which a any substance has been added thereto poultry product is enclosed for the pur- or mixed or packed therewith so as to pose of display and sale to household increase its bulk or weight, or reduce consumers. its quality or strength, or make it ap- Container. The term ‘‘container’’ in- pear better or of greater value than it cludes any box, can, tin, cloth, plastic, is. or any other receptacle, wrapper, or Animal food. Any article intended for cover. use as food for dogs, cats, or other ani- Edible. This term means that an arti- mals, derived wholly, or in part, from cle is intended for use as human food. carcasses or parts or products of the Egg Products Inspection Act. ‘‘Egg carcass of poultry, except that the Products Inspection Act’’ means the term animal food as used herein does Act so entitled, approved December 29, not include (i) processed dry animal 1970 (84 Stat. 1620, 21 U.S.C. 1031 et seq.). food or (ii) livestock or poultry feeds Federal Food, Drug, and Cosmetic Act. manufactured from processed poultry ‘‘Federal Food, Drug, and Cosmetic byproducts (such as poultry byproduct Act’’ means the Act so entitled, ap- meal, hydrolyzed poultry feathers, and proved June 25, 1938 (52 Stat. 1040), and hydrolyzed poultry byproducts aggre- acts amendatory thereof or supple- mentary thereto (21 U.S.C. 301 et seq.). gate). Federal Meat Inspection Act. ‘‘Federal Animal food manufacturer. ‘‘Animal Meat Inspection Act’’ means the Act so Food Manufacturer’’ means any person entitled, approved March 4, 1907, 34 engaged in the business of manufac- Stat. 1260, as amended by the Whole- turing or processing animal food. some Meat Act, 81 Stat. 584 (21 U.S.C. Applicant. ‘‘Applicant’’ means any 601 et seq.). person who requests inspection service, Free from protruding pinfeathers. exemption, or other authorization ‘‘Free from protruding pinfeathers’’ under the regulations. means that the carcass is free from Biological residue. ‘‘Biological Res- protruding pinfeathers which are visi- idue’’ means any substance, including ble to an inspector during an examina- metabolites, remaining in poultry at tion of the carcass at normal operating the time of slaughter or in any of its speeds. However, a carcass may be con- tissues after slaughter, as the result of sidered as being free from protruding treatment or exposure of the live poul- pinfeathers if it has a generally clean try to a pesticide, organic compound, appearance (especially on the breast), metallic or other inorganic compound, and if not more than an occasional pro- hormone, hormone-like substance, truding pinfeather is in evidence dur- growth promoter, antibiotic, anthel- ing a more careful examination of the mintic, tranquilizer, or other agent carcass. that leaves a residue. Giblets. ‘‘Giblets’’ means the liver Capable of use as human food. The from which the bile sac has been re- term ‘‘capable of use as human food’’ moved, the heart from which the peri- applies to any carcass, or part or prod- cardial sac has been removed, and the uct of a carcass of any poultry, unless gizzard from which the lining and con- it is denatured or otherwise identified tents have been removed: Provided, as required by the regulations, or it is That each such organ has been prop- naturally inedible by humans. erly trimmed and washed. Carcass. This term means all parts, Immediate container. ‘‘Immediate con- including viscera, of any slaughtered tainer’’ includes any consumer pack- poultry. age; or any other container in which

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poultry products, not consumer pack- words, statements, designs, or devices, aged, are packed. in the labeling) and in such terms as to Inedible. This term means any car- render it likely to be read and under- cass or any part of a carcass that is ei- stood by the ordinary individual under ther naturally inedible by humans or is customary conditions of purchase and rendered unfit for human food by rea- use; son of adulteration or denaturing. (vii) If it purports to be or is rep- Inspected for wholesomeness. This term resented as a food for which a defini- means that the poultry product so tion and standard of identity or com- identified has been inspected and was position is prescribed by the regula- found at the time of such inspection to tions in subpart P of this part unless: be not adulterated. (a) It conforms to such definition and Inspection. ‘‘Inspection’’ means any standard, and inspection required by the regulations (b) Its label bears the name of the to determine whether any poultry or food specified in the definition and poultry products comply with the re- standard, and insofar as may be requirements of the Act and the regula- quired by such regulations, the com- tions. mon names of optional ingredients Label. This term applies to any dis- (other than spices, flavoring, and color- play of written, printed, or graphic ing) present in such food. matter upon any article or the imme- (viii) If it purports to be or is rep- diate container (not including package resented as a food for which a standard liners) of any article. or standards of fill of container have Labeling. This term applies to all la- been prescribed by regulations of the bels and other written, printed, or Secretary, 2 and falls below the stand- graphic matter (i) upon any article or ard of fill of container applicable there- any of its containers or wrappers, or to, unless its label bears, in such man- (ii) accompanying such article. ner and form as such regulations speci- Misbranded. This term applies to any fy, a statement that it falls below such poultry product under one or more of standard; the following circumstances: (ix) If it is not subject to the provi- (i) If its labeling is false or missions of paragraph (b)(vii) of this sec- leading in any particular; tion, unless its label bears: (ii) If it is offered for sale under the (a) The common or usual name of the name of another food; food, if any there be, and (iii) If it is an imitation of another (b) In case it is fabricated from two food, unless its label bears, in type of or more ingredients, the common or uniform size and prominence, the word usual name of each ingredient, except ‘‘imitation’’ and immediately there- as otherwise provided in § 381.118(c); after, the name of the food imitated; (x) If it purports to be or is rep- (iv) If its container is so made, resented for special dietary uses, unless formed, or filled as to be misleading; the label bears such information con- (v) If in a package or other container, cerning its vitamin, mineral, and other unless it bears a label showing: dietary properties as is required by (a) The name and place of business of § 381.124; the manufacturer, packer, or dis- (xi) If it bears or contains any artifi- tributor; and cial flavoring, artificial coloring, or (b) An accurate statement of the chemical preservative, unless it bears a quantity of the contents in terms of label stating that fact; except as other- weight, measure, or numerical count; wise provided in § 381.119, or except as otherwise provided in (xii) If it fails to bear, directly there- § 381.121(a) with respect to the quantity on or on its containers, when required of contents; by § 381.123, the official inspection leg- (vi) If any word, statement, or other end and the official establishment information required by or under au- number of the establishment where the thority of the Act to appear on the label or other labeling is not promi- 2 No such standards are currently in effect. nently placed thereon with such con- However, § 381.129 prohibits the use of false or spicuousness (as compared with other misleading containers.

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product was processed; and unre- regulations as under the Federal Food, stricted by any of the foregoing; such Drug, and Cosmetic Act. other information as the Adminis- Poultry. ‘‘Poultry’’ means any domes- trator may require in the regulations ticated bird (chickens, turkeys, ducks, to assure that it will not have false or geese, guineas, ratites, or squabs, also misleading labeling and that the public termed young pigeons from one to will be informed of the manner of han- about thirty days of age), whether live dling required to maintain the article or dead. in a wholesome condition. Poultry product. (i) This term means Nonfood compounds. Any substance any poultry carcass or part thereof; or proposed for use in official establish- any product which is made wholly or in ments, the intended use of which will part from any poultry carcass or part not result, directly or indirectly, in the thereof, excepting those exempted from substance becoming a component or definition as a poultry product in otherwise affecting the characteristics § 381.15. Except where the context re- of poultry or poultry products, exclud- quires otherwise (e.g., in paragraph ing labeling and packaging materials (b)(42) of this section), this term is lim- as covered in subpart N of this part. ited to articles capable of use as human Official certificate. This term means food. any certificate prescribed in subpart M (ii) Poultry food product. This term of this part relating to poultry or poul- means any product capable of use as try products. human food which is made in part from Official device. This term means any any poultry carcass or part thereof, ex- label or other device prescribed in sub- cepting those exempted from definition part M of this part for use in applying as a poultry product in § 381.15. any official mark. Poultry products broker. ‘‘Poultry Official establishment. ‘‘Official estab- products broker’’ means any person en- lishment’’ means any establishment as gaged in the business of buying or sell- determined by the Administrator at ing poultry products on commission, or which inspection of the slaughter of otherwise negotiating purchases or poultry, or the processing of poultry sales of such articles other than for his products, is maintained pursuant to own account or as an employee of an- the regulations. other person. Official import inspection establishment. Process. Process used as a verb means This term means any establishment, to conduct any operation or combina- other than an official establishment as tion of operations, whereby poultry is defined in this definition where inspec- slaughtered, eviscerated, canned, salt- tions are authorized to be conducted as ed, stuffed, rendered, boned, cut up, or prescribed in § 381.199. otherwise manufactured or processed. Official inspection legend. This term The term ‘‘process’’ does not refer to means the official inspection mark pre- freezing of poultry products, except scribed in § 381.96 or the official poultry when freezing is incidental to oper- identification mark prescribed in ations otherwise classed as ‘‘proc- § 381.97, showing that an article was in- essing’’ under this paragraph. spected for wholesomeness and passed Process authority. A person or organi- in accordance with the Act. zation with expert knowledge in poul- Official mark. This term means any try production process control and rel- symbol prescribed in subpart M of this evant regulations. part to identify the status of any arti- Process schedule. A written descrip- cle or poultry under the Act. tion of processing procedures, con- Packaging material. Any cloth, paper, sisting of any number of specific, dis- plastic, metal, or other material used tinct, and ordered operations directly to form a container, wrapper, label, or under control of the establishment em- cover for poultry products. ployed in the manufacture of a specific Pesticide chemical, food additive, color product, including the control, moni- additive, raw agricultural commodity. toring, verification, validation, and These terms shall have the same mean- corrective action activities associated ings for the purposes of the Act and the with production.

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Ready-to-cook poultry. ‘‘Ready-to- articles which are held in official cus- cook poultry’’ means any slaughtered tody in accordance with section 19 of poultry free from protruding pin- the Act and § 381.210, pending disposal feathers and vestigial feathers (hair or as provided in said section 19. down), from which the head, feet, crop, U.S. Refused Entry. This term means oil gland, trachea, esophagus, entrails, that the slaughtered poultry or other and lungs have been removed, and from poultry product so identified was pre- which the mature reproductive organs sented for inspection for entry into the and kidneys may have been removed, United States and was found not to and with or without the giblets, and comply with the requirements of the which is suitable for cooking without Act. need of further processing. Ready-to- U.S. Rejected. This term means that cook poultry also means any cut-up or the equipment or facility so identified disjointed portion of poultry or other is prohibited from being used in the parts of poultry, such as reproductive processing of any poultry or poultry organs, head, or feet that are suitable for cooking without need of further product until such equipment or facil- processing. ity is found by an inspector to be sani- Regulations. ‘‘Regulations’’ means the tary and otherwise eligible for use provisions of this entire part. under the regulations. Renderer. ‘‘Renderer’’ means any per- U.S. Retained. This term means that son engaged in the business of ren- the poultry or carcass, or part or prod- dering carcasses, or parts or products uct of a carcass, of poultry so identi- of the carcasses, of poultry, except ren- fied is held at an official establishment dering conducted under inspection or by the inspection service for further exemption pursuant to the regulations. determination as to its disposal. Shipping container. ‘‘Shipping con- (c) For the purposes of the standard tainer’’ means any container used or for cooked, smoked sausage (§ 319.180 of intended for use in packaging the prod- this chapter), the term ‘‘poultry by- uct packed in an immediate container. product’’ means the skin, fat, gizzard, Slaughter. ‘‘Slaughter’’ means the act heart, or liver, or any combination of killing poultry for human food. thereof, of any poultry. State. Except as otherwise provided in § 381.220 ‘‘State’’ means any State of [37 FR 9706; May 16, 1972, as amended at 39 FR 4568, Feb. 5, 1974; 40 FR 42338, Sept. 12, the United States and the Common- 1975; 48 FR 6091, Feb. 10, 1983; 49 FR 2236, Jan. wealth of Puerto Rico. 19, 1984; 49 FR 3643, Jan. 30, 1984; 49 FR 47478, Supervision. This term means the con- Dec. 5, 1984; 51 FR 37709, Oct. 24, 1986; 64 FR trols, as prescribed in instructions to 745, Jan. 6, 1999; 64 FR 56416, Oct. 20, 1999; 66 Inspection Service employees, to be ex- FR 1770, Jan. 9, 2001; 66 FR 22905, May 7, 2001; ercised by them over particular oper- 67 FR 13258, Mar. 22, 2002; 69 FR 255, Jan. 5, ations to insure that such operations 2004; 79 FR 56233, Sept. 19, 2014] are conducted in compliance with the Act and the regulations in this part. Subpart B—Administration; Appli- Territory. The term ‘‘territory’’ cation of Inspection and means Guam, the Virgin Islands of the Other Requirements United States, American Samoa, and any other territory or possession of the § 381.3 Administration. United States, excluding the Canal Zone. (a) [Reserved] United States. This term means the (b) The Administrator may in spe- States, the District of Columbia, and cific classes of cases waive for limited the territories of the United States. periods any provisions of the regula- U.S. Condemned. This term means tions in order to permit appropriate that the poultry carcass, or part or and necessary action in the event of a product of a poultry carcass, so identi- public health emergency or to permit fied was inspected and found to be experimentation so that new proce- adulterated and is condemned. dures, equipment, and processing tech- U.S. Detained. This term is applicable niques may be tested to facilitate defi- to poultry, poultry products, and other nite improvements: Provided, That such

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waivers of the provisions of the regula- (A) Knowledge of appropriate manu- tions are not in conflict with the pur- facturing practices and applicable reg- poses or provisions of the Act. ulatory requirements, (c) Pursuant to section 6 of the Act, (B) Demonstrated ability to apply the Administrator believes that, in es- such knowledge in a timely and con- tablishments processing poultry prod- sistent manner, and ucts at which inspection under the Act (C) Commitment to correcting defi- and regulations is required, the fre- ciencies noted by Inspection Service quency with which and the manner in employees and otherwise assuring com- which poultry products made from pliance with applicable regulatory re- poultry previously slaughtered and quirements, and eviscerated in official establishments (iii) The procedures used in such es- are reinspected by Inspection Service tablishment to control the production employees should be based on consider- process, environment, and resulting ations relevant to effective regulation product in order to assure and monitor of poultry products and protection of compliance with the requirements of the health and welfare of consumers. In the Act and the rules and regulations order to test procedures for use in promulgated thereunder. making such determinations and, in (2) In assessing the characteristics of particular, for determining whether an establishment, the following factors and, if so, to what extent the intensity are appropriate for consideration: of inspection coverage exceeds that (i) The complexity of the processing which should be deemed necessary pur- operation(s) conducted at such estab- suant to section 6 of the Act, the Ad- lishment, ministrator is initiating experimen- (ii) The frequency with which each tation of a new system of inspection such operation is conducted at such es- for reviewing the performance of estab- tablishment, lishments and for designing the super- (iii) The volume of product resulting vision and other conditions and meth- from each such operation at such es- ods of inspection coverage. For the pe- tablishment, riod of such experimentation, the Ad- (iv) Whether and to what extent ministrator shall identify establish- slaughter and evisceration operations ments for review, and the frequency also are conducted at such establish- and the manner of inspection by In- ment, spection Service employees shall be de- (v) What, if any, food products not termined on the basis of the results of regulated under this Act or the Federal those reviews and be otherwise in ac- Meat Inspection Act also are processed cordance with this section. at such establishment, and (d) The determinations referred to in (vi) The size of such establishment. paragraph (c) of this section shall be (e)(1) For the period of experimen- made by the Inspection Service and tation described in paragraph (c) of shall reflect evaluations of the per- this section, the frequency of inspec- formance and the characteristics of tion by Inspection Service employees such establishments. of operations other than slaughter and (1) In assessing the performance of an evisceration may be reduced in an es- establishment, the following factors tablishment in which the procedures are appropriate for consideration: referred to therein are being tested if (i) The history of compliance with and only if the evaluation of the per- applicable regulatory requirements by formance of such establishment de- the person operating such establish- scribed in paragraph (d)(1) indicates ment or by anyone responsibly con- that there are: nected with the business operating (i) No instances, documented in such establishment, as ‘‘responsibly records compiled no earlier than 10 connected’’ is defined in section 18(a) of years before, of substantial and recent the Act, noncompliance with applicable regu- (ii) The competence of the person op- latory requirements (taking into ac- erating such establishment, as indi- count both the nature and frequency of cated by: any such noncompliance), and

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(ii) The competence and control pro- (a) Every establishment, except as cedures needed to assure and monitor provided in § 381.10 (a) and (b) or § 381.11, compliance with applicable regulatory in which any poultry is slaughtered for requirements. transportation or sale in commerce, or (2)(i) The frequency of Federal in- in which any poultry products are spection and other conditions and wholly or in part, processed for trans- methods of inspection coverage in any portation or sale in commerce, as arti- establishment in which the frequency cles intended for use as human food; of Federal inspection is reduced shall (b) Every establishment, except as be based on: provided in § 381.10 (a) and (b), (c), or (A) The evaluation of the character- (d), or § 381.11, within any State or or- istics of such establishment described ganized territory which is designated in paragraph (d)(2) of this section, 1 in § 381.221 pursuant to section 5(c) of (B) The significance of potential pub- the Act, at which any poultry is lic health consequences of noncompli- slaughtered or any poultry products ance, and are processed, for use as human food (C) The availability of Inspection solely for distribution within such ju- Service employees. risdiction; and (ii) To the extent that frequency of (c) Except as provided in § 381.10 (a) inspection or other conditions and and (b), or (c), or § 381.11, every estab- methods of inspection coverage are lishment designated by the Adminis- identified as conflicting with provi- trator pursuant to section 5(c) of the sions of the regulations in this part, Act as one producing adulterated poul- the Administrator will waive such pro- try products which would clearly en- visions for the period of experimen- danger the public health. tation, in accordance with paragraph (b) of this section. § 381.7 Coverage of all poultry and poultry products processed in offi- [37 FR 9706, May 16, 1972, as amended at 52 cial establishments. FR 10033, Mar. 30, 1987; 69 FR 255, Jan. 5, 2004] All poultry and poultry products § 381.4 Inspection in accordance with processed in an official establishment methods prescribed or approved. shall be inspected, handled, processed, Inspection of poultry products shall marked, and labeled as required by the be rendered pursuant to the regula- regulations. tions and under such conditions and in accordance with such methods as may Subpart C—Exemptions be prescribed or approved by the Ad- ministrator. § 381.10 Exemptions for specified operations. § 381.5 Publications. (a) The requirements of the Act and Publications under the Act and the the regulations for inspection of the regulations shall be made in the FED- processing of poultry and poultry prod- ERAL REGISTER and in such other media ucts shall not apply to: as the Administrator may designate. (1) Any retail dealer with respect to poultry products sold in commerce di- § 381.6 Establishments requiring in- rectly to consumers in an individual spection. retail store, if the only processing op- Inspection under the regulations is eration performed by such retail dealer required at: is the cutting up of poultry products on the premises where such sales to con- 1 These evaluations will be based upon sumers are made: Provided, That such guidelines developed by FSIS and the com- operation is conducted under such sani- plexity categorization in FSIS Directive tary standards, practices, and proce- 1030.2 (Documentation of Processing and dures as result in the preparation of Combination Assignments, 4/22/85). The poultry products that are not adulter- guidelines and Directive will be available for public inspection and copying in the Policy ated: And provided further, That the Office, Room 3168, South Agriculture Build- poultry products sold in commerce are ing, 14th Street and Independence Avenue, derived from poultry inspected and SW., Washington, DC. passed under the Act and such poultry

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products are not adulterated or mis- pable of use as human food: And pro- branded at the time of sale (except that vided further, That in lieu of complying the official inspection legend shall not with all the adulteration and mis- be used). (For the purposes of this sub- branding provisions of the Act, such paragraph, a retail dealer is any person poultry is healthy and is slaughtered who sells poultry products directly to and processed under such sanitary consumers as defined in paragraph standards, practices, and procedures as (d)(2)(vi) of this section and whose sales result in the preparation of poultry of poultry products to household con- products that are sound, clean and fit sumers constitute, in terms of dollar for human food, and the shipping con- value, at least 75 percent of his total tainers of such poultry products bear sales of poultry products.) the owner’s name and address and the (2) The slaughter of poultry, and the statement ‘‘Exempted—P.L. 90–492.’’ processing of poultry products, by any (5) The slaughtering of sound and person in any territory not organized healthy poultry and processing of poul- with a legislative body, solely for distribution within such territory: Pro- try products therefrom in any State or vided, That such poultry is sound and territory or the District of Columbia healthy and is slaughtered under such by any poultry producer on his own sanitary standards, practices, and pro- premises with respect to poultry raised cedures as result in the preparation of on his premises, and the distribution poultry products that are not adulter- by any person solely within such juris- ated: And provided further, That the diction of the poultry products derived poultry products are not adulterated or from such operations: Provided, That (i) misbranded when so distributed (except in lieu of complying with all the adul- that the official inspection legend shall teration provisions of the Act, such not be used). poultry is slaughtered and otherwise (3) The slaughtering by any person of processed and handled under such sani- poultry of his own raising, and the tary standards, practices, and proce- processing by him and transportation dures as result in the preparation of in commerce of the poultry products poultry products that are sound, clean, exclusively for use by him and mem- and fit for human food when so distrib- bers of his household and his non- uted; (ii) such poultry products when paying guests and employees: Provided, so distributed, bear (in lieu of labeling That in lieu of complying with all the that would otherwise be required) the adulteration and misbranding provi- producer’s name and address and the sions of the Act, such poultry is statement ‘‘Exempted—P.L. 90–492’’ healthy and is slaughtered and proc- and such poultry products are not oth- essed under such sanitary standards, erwise misbranded; (iii) such producer practices, and procedures as result in and distributor do not engage in the the preparation of poultry products current calendar year in the business that are sound, clean, and fit for of buying or selling any poultry or human food, and the shipping con- poultry products other than as speci- tainers of such poultry products bear fied in this paragraph (a) (5) or (6) of the producer’s name and address and this section; and (iv) neither such pro- the statement ‘‘Exempted—P.L. 90– ducer or distributor slaughters or proc- 492.’’ (4) The custom slaughter by any per- esses the products of more poultry son of poultry delivered by the owner than allowed by paragraph (b) of this thereof for such slaughter, and the section. processing by such slaughterer and (6) The slaughtering of sound and transportation in commerce of the healthy poultry or the processing of poultry products exclusively for use, in poultry products of such poultry in any the household of such owner, by him State or territory or the District of Co- and members of his household and his lumbia by any poultry producer or nonpaying guests and the employees: other person for distribution by him Provided, That such custom slaughterer solely within such jurisdiction directly does not engage in the business of buy- to household consumers, restaurants, ing or selling any poultry products ca- hotels, and boardinghouses, for use in

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their own dining rooms, or in the prep- person’s application, that such an ex- aration of meals for sales direct to con- emption will not impair effectuating sumers: Provided, That (i) in lieu of the purposes of the Act. complying with all the adulteration (c) The provisions of the Act and the provisions of the Act, such poultry is regulations do not apply to any poultry slaughtered and otherwise processed producer with respect to poultry, of his and handled under such sanitary stand- own raising on his own farm, which he ards, practices, and procedures as re- slaughters if: sult in the preparation of poultry prod- (1) Such producer slaughters not ucts that are sound, clean, and fit for more than 1,000 poultry during the cal- human food when distributed by such endar year for which this exemption is processor; (ii) such poultry products being determined; when so distributed bear (in lieu of la- (2) Such poultry producer does not beling that would otherwise be re- engage in buying or selling poultry quired) the processor’s name and ad- products other than those produced dress and the statement ‘‘Exempted— from poultry raised on his own farm; P.L. 90–492’’ and such poultry products and are not otherwise misbranded; (iii) (3) None of such poultry moves in such processor does not engage in the ‘‘commerce’’ (as defined in § 381.1). current calendar year in the business (d)(1) The requirements of the Act of buying or selling any poultry or and the regulations for inspection of poultry products other than as speci- the processing of poultry and poultry fied in this paragraph (a) (6) or (5) of products do not apply to operations of this section; and (iv) such processor types traditionally and usually con- does not exceed the volume limitation ducted at retail stores and restaurants, prescribed in paragraph (b) of this sec- when conducted at any retail store or tion. restaurant or similar-retail-type estab- (7) The operations and products of lishment for sale in normal retail small enterprises (including poultry quantities or service of such articles to producers) not exempted under para- consumers at such establishments. graphs (a) (1) through (6) of this section (2) For the purposes of paragraph that are engaged in any State or terri- (d)(1) of this section: tory or the District of Columbia in (i) Operations of types traditionally slaughtering and/or cutting up poultry and usually conducted at retail stores for distribution as carcasses or parts and restaurants include any processing thereof solely for distribution within of poultry products except canning of such jurisdiction; Provided, That (i) poultry products and except slaugh- such poultry is sound and healthy when tering of poultry unless such slaugh- slaughtered and is slaughtered and/or tering is conducted at a retail store cut up and handled under such sanitary with respect to live poultry purchased standards, practices and procedures as by the consumer at the retail store and result in the preparation of poultry processed by the retail store operator products that are not adulterated when in accordance with the consumer’s in- so distributed; and (ii) when so distrib- structions. uted, such poultry products are not (ii) A normal retail quantity is any misbranded (except that the official in- quantity of a poultry product pur- spection legend shall not be used). chased by a household consumer from a (b) No person qualifies for any ex- retail supplier that in the aggregate emption specified in paragraph (a)(5), does not exceed 75 pounds. A normal re- (6), or (7) of this section if, in the cur- tail quantity sold by a retail supplier rent calendar year, such person: to other than a household consumer is (1) Slaughters or processes the prod- any quantity that in the aggregate ucts of more than 20,000 poultry, or does not exceed 150 pounds. (2) Slaughters or processes poultry (iii) A retail store is any place of products at a facility used for slaugh- business where: tering or processing poultry products (a) The sales of poultry products are by any other person, except when the made to consumers only; Administrator grants such exemption (b) At least 75 percent, in terms of after determining, upon review of a dollar value, of total sales of product

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represents sales to household con- (b) The definition of a restaurant in- sumers and the total dollar value of cludes a caterer which delivers or sales of product to consumers other serves product in meals, or as entrees, than household consumers does not ex- only to individual consumers and oth- ceed the dollar limitation per calendar erwise meets the requirements of this year set by the Administrator. This paragraph. dollar limitation is a figure which will (c) For purposes of this paragraph, automatically be adjusted during the operations conducted as a restaurant first quarter of each calendar year, up- central kitchen facility shall be consid- ward or downward, whenever the Con- ered as being conducted at a restaurant sumer Price Index, published by the if the restaurant central kitchen pre- Bureau of Labor Statistics, Depart- pares poultry products that are ready ment of Labor, indicates a change in to eat when they leave such facility the price of this same volume of prod- (i.e., no further cooking or other prepa- uct which exceeds $500. Notice of the ration is needed, except that they may adjusted dollar limitation will be pub- be reheated prior to serving if chilled lished in the FEDERAL REGISTER. 1 during transportation), transported di- (c) Only federally or State inspected rectly to a receiving restaurant by its and passed, or exempted (or, as pro- own employees, without intervening vided in § 381.223, State or local agency transfer or storage, maintained in a inspected and passed or exempted) safe, unadulterated condition during poultry products are handled or used in transportation, and served in meals or the preparation of any poultry prod- as entrees only to customers at res- ucts; taurants, or through vending ma- (d) No sale of poultry products is chines, owned or operated by the same made in excess of a normal retail quan- person that owns or operates such fa- tity as defined in paragraph (d)(2)(ii) of cility, and which otherwise meets the this section; and requirement of this paragraph: Pro- (e) The processing of poultry prod- vided, That the requirements of ucts for sale is limited to traditional §§ 381.175 through 381.178 of this sub- and usual operations as defined in chapter apply to such facility. Provided paragraph (d)(2)(i) of this section. further, That the exempted facility (iv) Restaurants. (a) A restaurant is may be subject to inspection require- any establishment where: ments under the Act for as long as the (1) Poultry products are processed Administrator deems necessary if the only for sale or service in meals or as Administrator determines that the entrees directly to individual con- sanitary conditions or practices of the sumers at such establishments; facility or the processing procedures or (2) Only federally inspected and methods at the facility are such that passed, or exempted (or, as provided in any of its poultry products are ren- § 381.223, State or local agency in- dered adulterated. When the Adminis- spected and passed or exempted) poul- trator has made such determination try products are handled or used in the and subjected a restaurant central preparation of any poultry products; kitchen facility to such inspection re- (3) No sale of poultry products is quirements, the operator of such facil- made in excess of a normal retail quan- ity shall be afforded an opportunity to tity as defined in paragraph (d)(2)(ii) of dispute the Administrator’s determina- this section; and tion in a hearing pursuant to rules of (4) The processing of poultry prod- practice which will be adopted for this ucts is limited to traditional and usual proceeding. operations as defined in paragraph (v) A similar retail-type establish- (d)(2)(i) of this section. ment is any establishment which is a combination retail store and res- 1 The dollar limitation currently in effect taurant; any delicatessen which meets may be obtained by contacting Director, the requirements for a retail store or Slaughter Inspection Standards and Proce- dures Division, Technical Services, Food restaurant as prescribed in paragraph Safety and Inspection Service, U.S. Depart- (d)(2) (iii) or (iv) of this section; or ment of Agriculture, Washington, DC 20250 other establishment as determined by (202) 447–3219. the Administrator in specific cases.

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(vi) A consumer is any household which were prepared, inspected, and consumer, hotel, or restaurant, or passed in a cured or cooked form as similar institution as determined by ready-to-eat (i.e., no further cooking or the Administrator in specific cases. other preparation is needed) in compli- (3) Whenever any complaint is re- ance with the requirements of the Act ceived by the Administrator from any and these regulations; and the poultry person alleging that any retail estab- pizzas are to be served in public or pri- lishment or restaurant claiming ex- vate nonprofit institutions, provided emption under this paragraph (d) in that the poultry pizzas are ready to eat any designated State or organized ter- (i.e., no further cooking or other prepa- ritory listed in § 381.221 that is also ration is needed, except that they may identified in § 381.224 as a jurisdiction be reheated prior to serving if chilled that does not have or is not exercising during transportation), transported di- adequate authority with respect to rec- rectly to the receiving institution by ordkeeping requirements, has been op- employees of the preparing firm, re- erated in violation of the conditions ceiving institution, or a food service prescribed in this paragraph (d) for management company contracted to such exemption, and the Adminis- conduct food service at the public or trator, upon investigation of the com- private nonprofit institution, without plaint, has reason to believe that any intervening transfer or storage. such violation has occurred, he shall so (2) The definitions at Chapter 1, 1–102, notify the operator of the retail estab- except 1–102(z) and the provisions of lishment or restaurant and afford him Chapters 2 through 8, except sections 2– reasonable opportunity to present his 102 (a) and (b), 2–302(d), 2–403(a), 2– views informally with respect to the 403(c), 2–404, 2–405, 2–407, 2–502 through matter. Thereafter, if the Adminis- trator determines that such a violation 2–506, 2–508, 2–509, 4–105, 4–201(c), 4–208, has occurred, and that a requirement 5–101(a), 5–103, 5–104, 5–202(c), 5–203, and that the operator keep records con- 6–105, Part IV, of the Food and Drug cerning the operations of the retail es- Administration’s Food Service Sanita- tablishment or restaurant would effec- tion Manual (1976 Recommendations), tuate the purposes of the Act, the Ad- DHEW Publication No. (FDA) 78–2081, ministrator shall order the operator to which is incorporated by reference, maintain complete, accurate, and leg- shall apply to the facilities and oper- ible records of his total monthly pur- ations of businesses claiming this ex- chases and of his total monthly sales of emption. (These materials are incor- poultry and poultry products. Such porated as they exist on the date of ap- records shall separately show total proval. This incorporation by reference sales to household consumers and total was approved by the Director of the sales to other consumers, and shall be Federal Register in accordance with 5 maintained for the period prescribed in U.S.C. 552(a) and 1 CFR part 51. Copies § 381.177. If the operator maintains cop- may be purchased from the Super- ies of bills of lading, receiving and intendent of Documents, U.S. Govern- shipping invoices, warehouse receipts, ment Printing Office, Washington, DC or similar documents which give the 20402. It is also available for inspection information required herein, additional at the FSIS Hearing Clerk, room 3171, records are not required by this sub- South Building, Food Safety and In- paragraph. spection Service, U.S. Department of (4) The adulteration and misbranding Agriculture, Washington, DC 20250 or provisions of the Act and the regula- at the National Archives and Records tions other than the requirement of the Administration (NARA). For informa- official inspection legend, apply to ar- tion on the availability of this mate- ticles which are exempted from inspec- rial at NARA, call 202–741–6030, or go tion under this paragraph (d). to: http://www.archives.gov/ (e)(1) The requirements of the Act federallregister/ and the regulations in this subchapter codeloflfederallregulations/ for inspection of the preparation of ibrllocations.html. products do not apply to poultry pizzas (3) Facilities and operations of busi- containing poultry product ingredients nesses claiming this exemption shall

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also conform to the following require- as a hypochlorite and at a temperature ments: of at least 75 °F; or (i) Manual cleaning and sanitizing. (A) (3) Immersion for at least 1 minute in For manual washing, rinsing and sani- a clean solution containing at least 12.5 tizing of utensils and equipment, a sink parts per million of available iodine with not fewer than three compart- and having a pH not higher than 5.0 ments shall be provided and used. Sink and at a temperature of at least 75 °F; compartments shall be large enough to or permit the accommodation of the (4) Immersion in a clean solution equipment and utensils, and each com- containing any other chemical sani- partment of the sink shall be supplied tizing agent allowed under 21 CFR with hot and cold potable running 178.1010 that will provide the equiva- water. Fixed equipment and utensils lent bactericidal effect of a solution and equipment too large to be cleaned containing at least 50 parts per million in sink compartments shall be washed of available chlorine as a hypochlorite manually or cleaned through pressure at a temperature of at least 75 °F for 1 spray methods. minute; or (B) Drain boards or easily movable (5) Treatment with steam free from dish tables of adequate size shall be materials or additives other than those provided for proper handling of soiled specified in 21 CFR 173.310 in the case utensils prior to washing and for of equipment too large to sanitize by cleaned utensils following sanitizing immersion, but in which steam can be and shall be located so as not to inter- confined; or fere with the proper use of the dish- (6) Rinsing, spraying, or swabbing washing facilities. with a chemical sanitizing solution of (C) Equipment and utensils shall be at least twice the strength required for preflushed or prescraped and, when that particular sanitizing solution necessary, presoaked to remove gross under paragraph (e)(3)(i)(E)(4) of this food particles and soil. section in the case of equipment too (D) Except for fixed equipment and large to sanitize by immersion. utensils too large to be cleaned in sink (F) When hot water is used for sani- compartments, manual washing, rins- tizing, the following facilities shall be ing and sanitizing shall be conducted in provided and used: the following sequence: (1) An integral heating device or fix- (1) Sinks shall be cleaned prior to ture installed in, on, or under the sani- use. tizing compartment of the sink capable (2) Equipment and utensils shall be of maintaining the water at a tempera- thoroughly washed in the first com- ture of at least 170 °F; and partment with a hot detergent solution (2) A numerically scaled indicating that is kept clean. thermometer, accurate to ±3 °F, con- (3) Equipment and utensils shall be venient to the sink for frequent checks rinsed free of detergent and abrasives of water temperature; and with clean water in the second com- (3) Dish baskets of such size and department. sign to permit complete immersion of (4) Equipment and utensils shall be the tableware, kitchenware, and equip- sanitized in the third compartment ac- ment in the hot water. cording to one of the methods pre- (G) When chemicals are used for sani- scribed in paragraph (e)(3)(i)(E) (1) tization, they shall not have con- through (4) of this section. centrations higher than the maximum (E) The food-contact surfaces of all permitted under 21 CFR 178.1010 and a equipment and utensils shall be sani- test kit or other device that accurately tized by: measures the parts per million con- (1) Immersion for at least 1⁄2 minute centration of the solution shall be pro- in clean, hot water at a temperature of vided and used. at least 170 °F; or (ii) Mechanical cleaning and sanitizing. (2) Immersion for at least 1 minute in (A) Cleaning and sanitizing may be a clean solution containing at least 50 done by spray-type or immersion dish- parts per million of available chlorine washing machines or by any other type

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of machine or device if it is dem- dishwashing machine unless a onstrated that it thoroughly cleans prewashcycle is a part of the dish- and sanitizes equipment and utensils. washing machine operation. Equipment These machines and devices shall be and utensils shall be placed in racks, properly installed and maintained in trays, or baskets, or on conveyors, in a good repair. Machines and devices shall way that food-contact surfaces are ex- be operated in accordance with manu- posed to the unobstructed application facturers’ instructions, and utensils of detergent wash and clean rinse wa- and equipment placed in the machine ters and that permits free draining. shall be exposed to all dishwashing cy- (G) Machines (single-tank, sta- cles. Automatic detergent dispensers, tionary-rack, door-type machines and wetting agent dispensers, and liquid spray-type glass washers) using chemi- sanitizer injectors, if any, shall be cals for sanitization may be used: Pro- properly installed and maintained. vided, That, (B) The pressure of final rinse water (1) The temperature of the wash supplied to spray-type dishwashing ma- water shall not be less than 120 °F. chines shall not be less than 15 nor (2) The wash water shall be kept more than 25 pounds per square inch clean. measured in the water line imme- (3) Chemicals added for sanitization diately adjacent to the final rinse con- purposes shall be automatically dis- trol valve. A 1⁄4-inch IPS valve shall be pensed. provided immediately upstream from (4) Utensils and equipment shall be the final rinse control valve to permit exposed to the final chemical sani- checking the flow pressure of the final tizing rinse in accordance with manu- rinse water. facturers’ specifications for time and (C) Machine or water line mounted concentration. numerically scaled indicating ther- (5) The chemical sanitizing rinse mometers, accurate to ±3 °F, shall be water temperature shall be not less ° provided to indicate the temperature of than 75 F nor less than the tempera- the water in each tank of the machine ture specified by the machine’s manu- and the temperature of the final rinse facturer. water as it enters the manifold. (6) Chemical sanitizers used shall (D) Rinse water tanks shall be pro- meet the requirements of 21 CFR 178.1010. tected by baffles, curtains, or other ef- (7) A test kit or other device that ac- fective means to minimize the entry of curately measures the parts per mil- wash water into the rinse water. Con- lion concentration of the solution shall veyors in dishwashing machines shall be available and used. be accurately timed to assure proper (H) Machines using hot water for exposure times in wash and rinse cy- sanitizing may be used provided that cles in accordance with manufacturers’ wash water and pumped rinse water specifications attached to the ma- shall be kept clean and water shall be chines. maintained at not less than the fol- (E) Drain boards shall be provided lowing temperatures: and be of adequate size for the proper (1) Single-tank, stationary-rack, handling of soiled utensils prior to dual-temperature machine: washing and of cleaned utensils following sanitization and shall be so lo- Wash temperature ...... 150 °F cated and constructed as not to inter- Final rinse temperature ...... 180 °F fere with the proper use of the dish- (2) Single-tank, stationary-rack, sin- washing facilities. This does not pre- gle-temperature machine: clude the use of easily movable dish ta- ° bles for the storage of soiled utensils or Wash temperature ...... 165 F Final rinse temperature ...... 165 °F the use of easily movable dishtables for the storage of clean utensils following (3) Single-tank, conveyor machine: sanitization. Wash temperature ...... 160 °F (F) Equipment and utensils shall be Final rinse temperature ...... 180 °F flushed or scraped and, when necessary, soaked to remove gross food particles (4) Multitank, conveyor machine: and soil prior to being washed in a Wash temperature ...... 150 °F

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Pumped rinse temperature ...... 160 °F scribed in section 1.147(b) of the De- Final rinse temperature ...... 180 °F partment’s Uniform Rules of Practice (5) Single-tank, pot, pan, and utensil (7 CFR 1.147(b)). In those instances washer (either stationary or moving- where there is conflict of any material rack): fact, the owner or operator of the establishment, upon request, shall be af- ° Wash temperature ...... 140 F forded an opportunity for a hearing Final rinse temperature ...... 180 °F with respect to the disputed fact, in ac- (I) All dishwashing machines shall be cordance with rules of practice which thoroughly cleaned at least once a day shall be adopted for the proceeding. or more often when necessary to main- However, such withdrawal or modifica- tain them in a satisfactory operating tion shall become effective pending condition. final determination in the proceeding (iii) Steam. Steam used in contact when the Administrator determines with food or food-contact surfaces shall that an imminent threat to food safety be free from any materials or additives or public health exists, and that such other than those specified in 21 CFR action is, therefore, necessary to pro- 173.310. tect the public health, interest or safe- (4) For purposes of this paragraph, ty. Such withdrawal or modification the term ‘‘private nonprofit institu- shall be effective upon oral or written tion’’ means ‘‘a corporation, and any notification, whichever is earlier, to community chest, fund, or foundation, the owner or operator of the particular organized and operated exclusively for establishment as promptly as cir- religious, charitable, scientific, testing cumstances permit. In the event of oral for public safety, literary, or edu- notification, written confirmation cational purposes, or to foster national shall be given to the owner or operator or international amateur sports com- of the establishment as promptly as petition (but only if no part of its ac- circumstances permit. This withdrawal tivities involve the provision of ath- or modification shall continue in effect letic facilities or equipment), or for the pending the completion of the pro- prevention of cruelty to children or ceeding and any judicial review there- animals, no part of the net earnings of of, unless otherwise ordered by the Ad- which inures to the benefit of any pri- ministrator. vate shareholder or individual, no sub- (6) The adulteration and misbranding stantial part of the activities of which provisions of the Act and the regula- is carrying on propaganda, or other- tions apply to articles which are ex- wise attempting, to influence legisla- empted from inspection under tion, and which does not participate in, or intervene in (including the pub- § 381.10(e). lishing or distribution of statements), [37 FR 9706, May 16, 1972, as amended at 38 any political campaign on behalf of (or FR 16991, June 28, 1973; 45 FR 27922, Apr. 25, in opposition to) any candidate for pub- 1980; 46 FR 46288, Sept. 16, 1981; 48 FR 2959, lic office.’’ Jan. 24, 1983; 51 FR 29909, Aug. 21, 1986; 53 FR (5) The Administrator may withdraw 24679, June 30, 1988; 57 FR 34184, Aug. 3, 1992] or modify the exemption set forth in § 381.10(e)(1) for a particular establish- § 381.11 Exemptions based on religious dietary laws. ment when he or she determines that such action is necessary to ensure food (a) Any person who slaughters, proc- safety and public health. Before such esses, or otherwise handles poultry or action is taken, the owner or operator poultry products which have been or of the particular establishment shall be are to be processed as required by rec- notified, in writing, of the reasons for ognized religious dietary laws may the proposed action and shall be given apply for exemption from specific pro- an opportunity to respond, in writing, visions of the Act or regulations which to the Administrator within 20 days are in conflict with such religious die- after notification of the proposed ac- tary laws. Any person desiring such an tion. The written notification shall be exemption shall apply in writing to the served on the owner or operator of the Meat and Poultry Inspection Program, establishment in the manner pre- Food Safety and Inspection Service,

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Department of Agriculture, Wash- fied conditions, the sale, offer for sale, ington, DC 20250, setting forth the spe- transportation and other handling in cific provisions of the Act and the reg- commerce by any person of such poul- ulations from which exemption is try and poultry products in accordance sought and setting forth the provisions with such conditions is hereby author- of the religious dietary laws in support ized, except as restricted by the Act. of the requested exemption. In addition, the applicant for such an exemp- § 381.13 Suspension or termination of tion shall submit a statement from the exemptions. clerical official having jurisdiction (a) The Administrator may, by order, over the enforcement of the religious in accordance with the applicable rules dietary laws with respect to the poul- of practice suspend or terminate any try or poultry products involved, which exemption under § 381.10(a) with respect identifies the requirements of such to any person whenever he finds that laws pertaining to the slaughter of the such action will aid in effectuating the poultry and the processing or other purposes of the Act. Failure to comply handling of the poultry products in- with the conditions of the exemption, volved, and certifies that such require- including, but not limited to, failure to ments are in conflict with specific pro- process poultry and poultry products visions of the Act and regulations from under clean and sanitary conditions which the exemption is sought. may result in termination of an exemp- (b) The Administrator, upon a deter- tion, in addition to any other penalties mination that an exemption should be provided by law. granted, will grant such exemption to (b) Except as provided in § 381.10(c), the extent necessary to avoid conflict the Administrator may extend the re- with the religious requirements while quirements of the Act to any establish- still effectuating the purposes of the ment in any State or organized terri- Act. He may impose such conditions as tory at which poultry products are to sanitary standards, practices, and processed for distribution solely within procedures in granting such exemption such jurisdiction if he determines in as he deems necessary to effectuate the accordance with the provisions of sub- purposes of the Act. Any person who paragraph 5(c)(1) of the Act that the es- processes poultry or poultry products tablishment is producing adulterated under exemption from certain require- poultry products which would clearly ments as provided in this section shall endanger the public health. be subject to all of the other applicable provisions of the Act and the regula- § 381.14 Inspection concerning pur- tions. Processing plants shall meet the portedly exempted operations. sanitary requirements set forth in this Inspectors of the Inspection Service part and unless exempted from inspec- are authorized to make inspections in tion under the provisions of this sub- accordance with law to ascertain part, shall be required to qualify for in- whether any of the provisions of the spection and operate as official estab- Act or the regulations applying to pro- lishments. Slaughtered poultry which ducers, retailers, or other persons pur- is prepared under an exemption author- porting to be exempted from any re- izing the sale of noneviscerated poultry quirements under this subpart have in commerce shall be individually iden- been violated. tified with a label approved by the Ad- ministrator which identifies the cler- § 381.15 Exemption from definition of ical official under whose supervision ‘‘poultry product’’ of certain human the poultry was slaughtered. food products containing poultry. The following articles contain poul- § 381.12 Effect of religious dietary laws try ingredients only in a relatively exemptions on other persons. small proportion or historically have Whenever a slaughterer or processor not been considered by consumers as is granted an exemption under § 381.11 products of the poultry food industry. with respect to the slaughtering or Therefore said articles are exempted processing of any poultry or poultry from the definition of ‘‘poultry prod- products under this part, under speci- uct’’ and the requirements of the Act

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and the regulations applicable to poul- (c) Bouillon cubes, poultry broths, try products, if they comply with the gravies, sauces, seasonings, and conditions specified in this section. flavorings if: (a) Any human food product (in a (1) They contain poultry meat and/or consumer package) not provided for in ‘‘Mechanically Separated (Kind of paragraph (c) of this section, if: Poultry)’’ as defined in § 381.173 or poul- (1) It contains less than 2 percent try fat only in condimental quantities; cooked poultry meat (deboned white or (2) They comply with the provisions dark poultry meat, or both) and/or of paragraphs (a)(3), (4), and (5) of this ‘‘Mechanically Separated (Kind of section in all respects; and Poultry)’’ as defined in § 381.173; (3) In the case of poultry broth, it will not be used in the processing of (2) It contains less than 10 percent of any poultry product in any official es- cooked poultry skins, giblets, or fat, tablishment. separately, and less than 10 percent of (d) Fat capsules and sandwiches con- cooked poultry skins, giblets, fat, and taining poultry products if they com- meat (as meat is limited in paragraph ply with the provisions of paragraphs (a)(1) of this section) or ‘‘Mechanically (a)(3), (4), and (5) of this section in all Separated (Kind of Poultry)’’ as defined respects. in § 381.173, in any combination; (e) Products of the types specified in (3) The poultry ingredients used in this section except those specified in the product were prepared under in- paragraphs (c) and (d) of this section spection as defined in § 381.1, or were will be deemed to be represented as inspected under a foreign inspection poultry products if the kind name of system approved under § 381.196(b) and the poultry (chicken, turkey, etc.) is imported in compliance with the Act used in the product name of the prod- and the regulations; uct without appropriate qualification. (4) The immediate container of the For example, a consumer-packaged product bears a label which shows the noodle soup product containing less name of the product in accordance with than 2 percent chicken meat on a this section; and ready-to-serve basis may not be labeled (5) The product is not represented as ‘‘Chicken Noodle Soup’’ but, when ap- a poultry product. The aforesaid per- propriate, could be labeled as ‘‘Chicken centages of ingredients shall be com- Flavored Noodle Soup.’’ Products ex- puted on the basis of the moist, empted under this section are subject deboned, cooked poultry in the ready- to the requirements of the Federal to-serve product when prepared accord- Food, Drug, and Cosmetic Act. ing to the serving directions on the [37 FR 9706, May 16, 1972, as amended at 60 consumer package. FR 55982, Nov. 3, 1995] (b) Any human food product (in an institutional pack), not provided for in Subpart D—Application for In- paragraph (c) of this section, if: spection; Grant or Refusal of (1) It is prepared for sale only to in- Inspection stitutional users, such as hotels, restaurants, and boardinghouses, for use § 381.16 How application shall be as a soup base or flavoring; made. (2) It contains less than 15 percent The operator of each establishment cooked poultry meat (deboned white or of the kind required by § 381.6 to have dark poultry meat or both) and/or inspection shall make application to ‘‘Mechanically Separated (Kind of the Administrator for inspection serv- Poultry)’’ as defined in § 381.173, com- ice. In cases of change of name, owner- puted on the basis of the moist ship, or location, a new application deboned, cooked poultry meat and/or shall be made. ‘‘Mechanically Separated (Kind of Poultry)’’ in such product; and § 381.17 Filing of application. (3) It complies with the provisions of Every application for inspection at paragraphs (a)(3), (4), and (5) of this any establishment shall be made by the section in all respects. operator on a form furnished by the

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Meat and Poultry Inspection Program, istrator with a certification as pre- Food Safety and Inspection Service, scribed in said subsection that there is U.S. Department of Agriculture, Wash- reasonable assurance that such activ- ington, DC 20250, and shall include all ity will be conducted in a manner information called for by that form, in- which will not violate the applicable cluding the name of any subsidiary cor- water quality standards. No grant of poration that will prepare any poultry inspection can be issued after April 3, product or conduct any other operation 1970 (the date of enactment of the at the establishment for which inspec- Water Quality Improvement Act), un- tion is requested. The applicant for in- less such certification has been ob- spection will be held responsible for tained, or is waived because of failure compliance by all its subsidiaries with or refusal of the State, interstate agen- the requirements of the regulations at cy, or the Administrator of the Envi- such establishments if inspection is ronmental Protection Agency to act on granted. Processing of poultry products a request for certification within 1 year and other operations at the establish- after receipt of such request. Further, ment for which inspection is granted upon receipt of an application for in- may be conducted only by the appli- spection and a certification as required cant, except that such a subsidiary of by subsection 21(b) of the Federal the grantee, may conduct such oper- Water Pollution Control Act, the Ad- ations at such establishment. ministrator (as defined in § 381.1) is required by paragraph (2) of said sub- § 381.18 Authority of applicant. section to notify the Administrator of Any person applying for inspection the Environmental Protection Agency service may be required at the discre- for proceedings in accordance with that tion of the Administrator to dem- paragraph. No grant of inspection can onstrate that the operator of the estab- be made until the requirements of said lishment authorized him to do so. paragraph (2) have been met. (2) However, certification under sub- § 381.20 Survey and grant of inspec- section 21(b) of the Federal Water Pol- tion. lution Control Act is not initially re- (a) Before inspection is granted, FSIS quired in connection with an applica- shall survey the establishment to de- tion for inspection granted after April termine if the construction and facili- 3, 1970, for facilities existing or under ties of the establishment are in accord- construction on April 3, 1970, although ance with the regulations. FSIS will certification for such facilities is re- grant inspection, subject to § 381.21, quired to be obtained within the 3–year when these requirements are met. period immediately following April 3, (b) FSIS shall give notice in writing 1970. Failure to obtain such certifi- to each applicant granted inspection cation or to meet the other require- and shall specify in the notice the es- ments of subsection 21(b) prior to April tablishment, including the limits of 3, 1973, will result in the termination of the establishment’s premises, to which inspection at such facilities on that the grant pertains. date. [62 FR 45026, Aug. 25, 1997] (3) Further, any application for inspection pending on April 3, 1970, and § 381.21 Refusal of inspection. granted within 1 year thereafter shall (a) Any application for inspection in not require certification for 1 year fol- accordance with this part may be de- lowing the grant of inspection but such nied or refused in accordance with the grant of inspection shall terminate at rules of practice in part 500 of this the end of 1 year after its issuance un- chapter. less prior thereto such certification has (b)(1) Any applicant for inspection at been obtained and the other require- an establishment where the operations ments of subsection 21(b) are met. thereof may result in any discharge (4) In the case of any activity which into the navigable waters of the United will affect water quality but for which States is required by subsection 21(b) of there are no applicable water quality the Federal Water Pollution Control standards, no certification is required Act, as amended, to provide the Admin- prior to the grant of inspection but

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such grant will be conditioned upon a prepared in the establishment. An es- requirement of compliance with the tablishment shall not have more than purpose of the Federal Water Pollution one establishment number. Control Act as provided in paragraph 21(b)(9) of said Act. § 381.26 Separation of establishments. [37 FR 9706, May 16, 1972, as amended at 64 Each official establishment shall be FR 66545, Nov. 29, 1999] separate and distinct from any other official establishment and from any § 381.22 Conditions for receiving inspection. unofficial establishment except an establishment preparing meat products (a) Before being granted Federal in- under the Federal Meat Inspection Act spection, an official establishment or or under State meat inspection. Fur- an official import inspection establish- ther, doorways, or other openings, may ment, must have developed written Sanitation Standard Operating Proce- be permitted between establishments dures, as required by part 416 of this at the discretion of the Administrator chapter, and written recall procedures and under such conditions as he may as required by part 418 of this chapter. prescribe. (b) Before being granted Federal inspection, an establishment shall have § 381.27 Inauguration of service; notifi- conducted a hazard analysis and devel- cation concerning regulations; status of uninspected poultry prod- oped and validated a HACCP plan, in ucts. accordance with §§ 417.2 and 417.4 of this chapter. A conditional grant of inspec- The inspector in charge or his super- tion shall be issued for a period not to visor shall, upon or prior to the inau- exceed 90 days, during which period the guration of service, inform the oper- establishment must validate its ator of the establishment of the re- HACCP plan. quirements of the regulations. If the (c) Before producing new product for establishment at the time service is in- distribution in commerce, an establish- augurated contains any poultry prod- ment shall have conducted a hazard uct which has not been inspected and analysis and developed a HACCP plan marked in compliance with the regula- applicable to that product in accord- tions, its identity shall be maintained, ance with § 417.2 of this chapter. During and it shall not be represented or dealt a period not to exceed 90 days after the with as a product which has been in- date the new product is produced for spected. Such products may not be distribution in commerce, the estab- shipped in commerce unless such prod- lishment shall validate its HACCP ucts are eligible for such shipment plan, in accordance with § 417.4 of this under an exemption from inspection chapter. under subpart C and comply with all [61 FR 38866, July 25, 1996, as amended at 77 requirements of said subpart. FR 26936, May 8, 2012; 79 FR 56233, Sept. 19, 2014] § 381.28 Report of violations. Subpart E—Inauguration of In- Each inspector, agent, representative, or employee of the Inspection spection; Official Establish- Service shall report, in the manner pre- ment Numbers; Separation of scribed by the Administrator, all viola- Establishments and Other Re- tions of the Act and noncompliance quirements; Withdrawal of In- with the regulations of which he has spection knowledge. § 381.25 Official establishment numbers. An official establishment number shall be assigned to each establishment granted inspection service. Such number shall be used to identify all containers of inspected poultry products

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Subpart F—Assignment and Au- sion of an inspector relating to any in- thorities of Program Employ- spection, file an appeal from such deci- ees; Appeals sion: Provided, That such appeal is filed within 48 hours from the time the deci- §§ 381.30–381.31 [Reserved] sion was made. Any such appeal from a decision of an inspector shall be made § 381.32 Access to establishments. to his immediate superior having juris- [See § 300.6 of this chapter regarding diction over the subject matter of the access to establishments and other appeal, and such superior shall deter- places of business.] mine whether the inspector’s decision was correct. Review of such appeal de- [69 FR 255, Jan. 5, 2004] termination, when requested, shall be made by the immediate superior of the § 381.33 Identification. employee of the Department making Each inspector will be furnished with the appeal determination. The cost of a numbered official inspection badge, any such appeal shall be borne by the which shall remain in his or her posses- appellant if the Administrator deter- sion at all times, and which shall be mines that the appeal is frivolous. The worn in such manner and at such times charges for such frivolous appeal shall as the Administrator may prescribe. be at the rate of $9.28 per hour for the [59 FR 42156, Aug. 17, 1994, as amended at 69 time required to make the appeal in- FR 255, Jan. 5, 2004] spection. The poultry or poultry products involved in any appeal shall be § 381.34 Financial interest of inspec- identified by U.S. retained tags and tors. segregated in a manner approved by (a) No inspector shall inspect any the inspector pending completion of an poultry or poultry product in which he, appeal inspection. his spouse, minor child, partner, orga- [48 FR 11419, Mar. 18, 1983, as amended at 60 nization in which he is serving as offi- FR 67456, Dec. 29, 1995] cer, director, trustee, partner, or employee, or any person with whom he is negotiating or has any arrangement Subpart G—Facilities for Inspec- concerning prospective employment, is tion; Overtime and Holiday financially interested. Service; Billing Establishments (b) All inspectors are subject to stat- utory restrictions with respect to po- § 381.36 Facilities required. litical activities; e.g., 5 U.S.C. 7324 and (a) Inspector’s Office. Office space, in- 1502. cluding, but not being limited to fur- (c) Violation of the provisions of nishings, light, heat, and janitor serv- paragraph (a) of this section or the pro- ice, shall be provided rent free in the visions of applicable statutes ref- official establishment, for the use of erenced in paragraph (b) of this section Government personnel for official pur- will constitute grounds for dismissal in poses. The room or space set apart for the case of appointees and for revoca- this purpose must meet the approval of tion of licenses in the case of licensees. the Inspection Service and be conven- (d) Inspectors are subject to all appli- iently located, properly ventilated, and cable provisions of law and regulations provided with lockers or file cabinets and instructions of the Department suitable for the protection and storage and the Food Safety and Inspection of supplies and with facilities suitable Service and other authority concerning for inspectors to change clothing. At employee responsibilities and conduct. the discretion of the Administrator, The setting forth of certain prohibi- small plants requiring the services of tions in this part in no way limits the less than one full-time inspector need applicability of such general or other not furnish facilities for Program em- regulations or instructions. ployees as prescribed in this section, where adequate facilities exist in a § 381.35 Appeal inspections; how made. nearby convenient location. Each offi- Any person receiving inspection serv- cial establishment shall provide com- ice may, if dissatisfied with any deci- mercial laundry service for inspectors’

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outer work clothing, or disposable allow safe working conditions. The outer work garments designed for one- platform must have a safe lift mecha- time use, or uniform rental service gar- nism and be large enough for the in- ments which are laundered by the rent- spector to sit on a stool and to change al service. stations during breaks or station rota- (b) Facilities for ante mortem inspection. tion. A suspect pen is required for ade- (v) Conveyor line stop/start switches quate ratite inspection. shall be located within easy reach of (c) Facilities for the Streamlined In- each inspector. spection System (SIS). The following (vi) A trough or other facilities shall requirements for lines operating under extend beneath the conveyor at all SIS are in addition to the normal replaces where processing operations are quirements to obtain a grant of inspec- conducted from the point where the tion. The requirements for SIS in carcass is opened to the point where § 381.76(b) also apply. the trimming has been performed. The (1) The following provisions shall trough must be of sufficient width to apply to every inspection station: preclude trimmings, drippage, and de- (i) The conveyor line shall be level bris from accumulating on the floor or for the entire length of the inspection platforms. The clearance between the station. The vertical distance from the suspended carcasses and the trough bottom of the shackles to the top of must be sufficient to preclude contami- the adjustable platform (paragraph nation of carcasses by splash. (c)(1)(iv) of this section) in its lowest (vii) A minimum of 200-footcandles of position shall not be less than 60 shadow-free lighting with a minimum inches. color rendering index value of 85 where (ii) Floor space shall consist of 4 feet the birds are inspected to facilitate in- along the conveyor line for the inspec- spection. tor, and 4 feet for the establishment (viii) Online handrinsing facilities helper. A total of at least 8 feet along with a continuous flow of water must the conveyor line shall be supplied for be provided for and within easy reach one inspection station and 16 feet for of each inspector and each establish- two-inspection stations. ment helper. The hand-contact element (iii) Selectors or ‘‘kickouts’’ shall be must be rinsed automatically with a installed in establishments with two sufficient volume of water to remove inspection stations on a line so each in- all fat, tissue, debris, and other extra- spector will receive birds on 12-inch neous material from the hand contact centers with no intervening birds to element after each use. Both hot and impede inspection. The selector must cold running water shall be available move the bird to the edge of the trough at each inspection station on the evis- for the inspector and establishment cerating line and shall be delivered helper. The selectors must be smooth, through a suitable mixing device con- steady, and consistent in moving the trolled by the inspector. Alternatively, birds parallel and through the inspec- water for hand washing shall be deliv- tion station. Birds shall be selected and ered to such inspection stations at a released smoothly to avoid swinging minimum temperature of 65 degrees F. when entering the inspection station. (ix) Hangback racks shall be provided (iv) Each inspector’s station shall for and positioned within easy reach of have a platform that is slip-resistant the establishment helpers. and can be safely accessed by the in- (x) Each inspection station shall be spector. The platform shall be designed provided with receptacles for con- so that it can be easily and rapidly ad- demned carcasses and parts. Such re- justed for a minimum of 14 inches ceptacles shall comply with the per- vertically while standing on the plat- formance standards in § 416.3(c) of this form. The platform shall be a min- chapter. imum length of 4 feet and have a min- (2) The following provisions shall imum width of 2 feet; the platform apply only to prechill and postchill re- shall be designed with a 42-inch high inspection stations: rail on the back side and with 1⁄2-inch (i) Floor space shall consist of a min- foot bumpers on both sides and front to imum of 3 feet along each conveyor

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line and after each chiller to allow car- move the bird to the end of the trough casses to be removed for evaluation. for the presenter, inspector, and estab- The space shall be level and protected lishment helper. The selectors must be from all traffic and overhead obstruc- smooth, steady, and consistent in mov- tions. ing the birds parallel and through the (ii) The vertical distance from the inspection station. Birds shall be se- bottom of the shackles to the floor lected and released smoothly to avoid shall not be less than 48 inches. splashing the mirror (paragraph (iii) A table, at least 2 feet wide, 2 (d)(1)(vii) of this section) and swinging feet deep, and 3 feet high designed to be when entering the inspection station. readily cleanable and drainable shall Guide bars shall not extend in front of be provided for reinspecting the sam- the inspection station mirror to avoid pled birds. obstructing the inspector’s view. (iv) A minimum of 200-footcandles of (iv) Each inspector’s station shall shadow-free lighting with a minimum have an easily and rapidly adjustable color rendering index of 85 on the table platform, with a minimum of 14 inches surface shall be provided. of vertical adjustment, which covers (v) A separate clip board holder shall the entire length of the station (4 feet) be provided for holding the recording and has a minimum width of 2 feet. The sheets. platform shall be designed with a 42- (vi) Handwashing facilities shall be inch high rail on the back side and provided for and shall be within easy with 1⁄2-inch foot bumpers on both sides access of persons working at the sta- and front to allow safe working conditions. tions. (vii) Hangback racks designed to hold (v) Conveyor line stop/start switches 10 carcasses shall be provided for and shall be located within easy reach of positioned within easy reach of the per- each inspector. son at the station. (vi) A trough shall extend beneath (d) Facilities for the New Line Speed the conveyor at all places where proc- (NELS) inspection system. The fol- essing operations are conducted from lowing requirements for lines operating the point where the carcass is opened under the NELS inspection system are to the point where the trimming has in addition to the normal requirements been performed. The trough must be of to obtain a grant of inspection and to sufficient width to preclude trimmings, the requirements for NELS in § 381.76 drippage, and debris from accumu- (b) and (c). lating on the floor or platforms. The (1) The following provisions shall clearance between the suspended car- apply to every inspection station: casses and the trough must be suffi- (i) The conveyor line shall be level cient to preclude contamination of car- for the entire length of the inspection casses by splash. station. The vertical distance from the (vii) A distortion-free mirror, at least bottom of the shackles to the top of 3 feet wide and 2 feet high, shall be the adjustable platform (paragraph mounted at each inspection station so (d)(1)(iv) of this section) in its lowest that it can be adjusted between 5 and position shall not be less than 60 15 inches behind the shackles, tilt up inches. and down, tilt from side to side, and be (ii) Floor space shall consist of 6 feet raised and lowered. The mirror shall be along the conveyor line for the estab- positioned in relation to the inspection lishment employee presenting the platform so that the inspector can po- birds, 4 feet for the inspector, and 4 sition himself/herself opposite it 8 to 12 feet for the establishment helper. A inches from the downstream edge. The total of at least 42 feet along the con- mirror must be maintained abrasion veyor line shall be supplied for three free. inspection stations. (viii) A minimum of 200-footcandles (iii) Selectors or ‘‘kickouts’’ shall be of shadow-free lighting with minimum installed so the three inspection sta- color rendering index value of 85 1 where tions will receive birds on 18-inch centers with no intervening birds to im- 1 This requirement may be met by deluxe pede inspection. The selector must cool white type of fluorescent lighting.

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the birds are inspected to facilitate in- bottom of the shackles to the top of spection. A light shall also be posi- the adjustable platform (paragraph tioned above and slightly in front of (e)(1)(iii) of this section) in its lowest the mirror to facilitate the illumina- position shall not be less than 60 tion of the bird and mirror surfaces. inches. (ix) ‘‘One-line’’ handrinsing facilities (ii) Floor space shall consist of 8 feet with a continuous flow of water shall along the conveyor line; at least 4 feet be provided for and within easy reach for the inspector, and at least 4 feet for of each inspector and each establish- the establishment helper. ment presenter and helper. (iii) The inspector’s station shall (x) Hangback racks shall be provided have an easily and rapidly adjustable for and positioned within easy reach of the establishment helpers. platform with a minimum width of 2 (xi) Each inspection station shall be feet which covers the entire length of provided with receptacle for con- the station (4 feet). The platform must demned carcasses and parts. Such re- adjust vertically a minimum of 14 ceptacles shall comply with the per- inches, and must have a 42-inch rail on formance standards in § 416.3(c) of this the back side and 1⁄2-inch foot bumpers chapter. on the sides and the front to allow safe (2) The following provisions shall working conditions. apply only to the reinspection station: (iv) Conveyor line stop/start switches (i) Floor space shall consist of 6 feet shall be located within easy reach of along the conveyor line. The space each inspector. shall be level and protected from all (v) A trough or other facilities shall traffic and overhead obstructions. extend beneath the conveyor at all (ii) The vertical distance from the places where processing operations are bottom of the shackles to the floor conducted from the point where the shall not be less than 48 inches. carcass is opened to the point where (iii) A table, at least 3 feet wide and the trimming has been performed. The 2 feet deep, shall be provided for re- trough must be wide enough to prevent inspecting the sample birds. trimmings, drippage, and debris from (iv) A minimum of 200-footcandles of accumulation on the floor or plat- shows free lighting with a minimum forms. The clearance between sus- color rendering index of 85 1 on the table surface. pended carcasses and the trough must (v) A separate clip board holder shall be sufficient to prevent contamination be provided for holding the recording of carcasses by splash. sheets. (vi) A minimum of 200 foot-candles of (vi) Handwashing facilities shall be shadow-free lighting with a minimum provided for and shall be within easy color rendering index value of 85 1 reach of persons working at the sta- where the birds are inspected to facili- tion. tate inspection is required. The min- (vii) Hangback racks designed to hold imum lighting requirement for inspec- 10 carcasses shall be provided for and tion stations in § 381.52(b) shall not positioned within easy reach of the per- apply. son at the station. (vii) On-line handrinsing facilities (e) Facilities for the New Turkey In- with a continuous flow of water shall spection (NTI) System. The following be provided for and within easy reach requirements for lines operating under of each inspector and each establish- the NTI System are in addition to the ment helper. normal requirements to obtain a grant (viii) Hangback racks shall be pro- of inspection and to the requirements vided for and within easy reach of the for the NTI System in § 381.76 (b) and establishment helper. (c). (1) The following provisions apply to every inspection station: (i) The conveyor line must be level for the entire length of the inspection 1 This requirement may be met by deluxe station. The vertical distance from the cool white fluorescent lighting.

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(ix) Each inspection station shall be graph (f)(1)(iii) of this section) must provided with receptacles for con- not be less than 60 inches. demned carcasses and parts. Such re- (iii) Each online carcass inspection ceptacles shall comply with the per- station must have a platform that is formance standards in § 416.3(c) of this slip-resistant and can be safely chapter. accessed by the inspector. The plat- (2) The following provisions shall form must be designed so that it can be apply only to the reinspection station: easily and rapidly adjusted for a min- (i) Floor space shall consist of a minimum of 14 inches vertically while imum of 3 feet along the conveyor line standing on the platform. The platform so carcasses can be removed from each must be a minimum length of 4 feet line for evaluation. The space shall be and have a minimum width of 2 feet. level and protected from all traffic and The platform must be designed with a overhead obstructions. 42-inch high rail on the back side and (ii) The vertical distance from the with 1⁄2-inch foot bumpers on both sides bottom of the shackles to the floor and front to allow safe working condi- must not be less than 48 inches. tions. The platform must have a safe (iii) A table at least 3 feet wide and 2 lift mechanism and be large enough for feet deep designed to be readily clean- the inspector to sit on a stool and to able and drainable shall be provided for change stations during breaks or sta- reinspecting the sampled birds. tion rotation. (iv) A minimum of 200 foot-candles of (iv) Conveyor line stop/start switches shadow-free lighting with a minimum must be located within easy reach of 1 color rendering index of 85 at the the online carcass inspector. table surface is required. (v) A minimum of 200 foot-candles of (v) A clipboard holder shall be pro- shadow-free lighting with a minimum vided for holding the recording sheets. color rendering index value of 85 must (vi) Handwashing facilities shall be be provided where the birds are in- provided for and within easy reach of spected to facilitate online carcass in- persons working at the station. spection. (vii) Hangback racks designed to hold (vi) Hand rinsing facilities must be 10 carcasses shall be provided for and positioned within easy reach of the per- provided for use by and within easy son at this station. reach of the online carcass inspector. The hand rinsing facilities must have a (f) Facilities for post-mortem inspection continuous flow of water or be capable under the New Poultry Inspection System. The following facilities requirements of being immediately activated and de- apply to establishments operating activated in a hands-free manner, must under the New Poultry Inspection Sys- minimize any splash effect, and must tem and are in addition to the require- otherwise operate in a sanitary manner ments for obtaining a grant of inspec- that prevents contamination of car- tion. casses and inspector clothing. The (1) The following provisions apply to hand rinsing facilities must provide the online carcass inspection station: water at a temperature between 65 and (i) On each production line, at a point 120 degrees Fahrenheit. before the chiller and after the estab- (vii) A separate clipboard holder for lishment has completed all sorting, holding recording sheets must be pro- trimming, and reprocessing activities vided for and within easy reach of the necessary to comply with online carcass inspector. § 381.76(b)(6)(ii), at least 4 feet of floor (viii) Receptacles for condemned car- space along the conveyor line must be casses and parts that comply with the provided for one online carcass inspec- performance standards in § 416.3(c) of tion station. this chapter must be provided at each (ii) The conveyor line must be level online carcass inspection station. for the entire length of the online car- (ix) Hangback racks designed to hold cass inspection station. The vertical at least 10 carcasses must be provided distance from the bottom of the shack- and positioned within easy reach of the les to the top of the platform (para- online carcass inspector.

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(x) A buzzer shall be located within (viii) Hand washing facilities must be easy reach of the online carcass inspec- provided within easy access of all off- tor to be used by the carcass inspector line verification inspection stations. to alert the inspector-in-charge, offline (3) Each young chicken establish- inspectors, or establishment management operating under the New Poultry ment of conditions that require their Inspection System must provide a loca- attention. tion at a point along the production (2) The following provisions apply to line after the carcasses are eviscerated pre-chill and post-chill offline at which an inspector may safely and verification inspection stations: properly inspect for leukosis the first (i) One or more offline verification 300 carcasses of each flock together inspection stations must be located at with associated viscera either uni- the end of the line or lines prior to the formly trailing or leading, or otherwise chiller. One or more offline verification identified with the corresponding car- inspection stations must also be lo- cass. The leukosis inspection area must cated after the chiller or chillers. The provide a minimum of 200 foot-candles Agency will determine the total num- of shadow-free lighting on the surface ber of offline verification inspection where the viscera are inspected. stations needed in establishments hav- (4) A trough or other similar draining more than one processing line or age facility must extend beneath the more than one chiller. conveyor at all places where processing (ii) Floor space for all offline operations are conducted from the verification inspection stations must point where the carcass is opened to consist of a minimum of 3 feet along the point where trimming has been per- each conveyor line and after each chill- formed. The trough must be of suffi- er, as applicable, to allow carcasses to cient width to preclude trimmings, be removed for evaluation by the drippage, and debris from accumu- verification inspector. The space must lating on the floor or platforms. The be level and protected from all traffic clearance between suspended carcasses and overhead obstructions. and the trough must be sufficient to (iii) At the pre-chill location, the preclude contamination of carcasses by vertical distance from the bottom of splashing. the shackles to the floor must not be [37 FR 9706, May 16, 1972, as amended at 38 less than 48 inches. FR 9794, Apr. 20, 1973; 47 FR 23434, May 28, (iv) At each offline verification in- 1982; 49 FR 42554, Oct. 23, 1984; 50 FR 37512, spection station, a table designed to be Sept. 16, 1985; 52 FR 39209, Oct. 21, 1987; 64 FR readily cleanable and drainable must 56416, Oct. 20, 1999; 66 FR 22905, May 7, 2001; be provided for offline verification in- 79 FR 49633, Aug. 21, 2014] spectors to conduct offline verification activities. At turkey slaughter estab- § 381.37 Schedule of operations. lishments, the table must be at least 3 (a) No operations requiring inspec- feet wide, 2 feet deep, and 3 feet high. tion shall be conducted except under At all other poultry slaughter estab- the supervision of an Inspection Serv- lishments, the table must be at least 2 ice employee. All eviscerating of poul- feet wide, 2 feet deep, and 3 feet high try and further processing shall be (v) A minimum of 200 foot-candles of done with reasonable speed, consid- shadow-free lighting with a minimum ering the official establishment’s fa- color rendering index of 85 on the table cilities. surface must be provided. (b) A shift is a regularly scheduled (vi) The establishment must provide operating period, exclusive of meal- a separate clipboard holder for holding time. One lunch period is the only offi- recording sheets; or alternatively, the cial authorized interruption in the in- establishment may provide electronic spector’s tour of duty once it begins. means for the offline verification in- Lunch periods may be 30 minutes, 45 spector to record inspection results. minutes, or in any case may not exceed (vii) Hangback racks designed to hold one hour in duration. Once established, at least 10 carcasses must be provided the lunch period must remain rel- and positioned within easy reach of the atively constant as to time and dura- offline verification inspector. tion. Lunch periods for inspectors shall

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not, except as provided herein, occur daily clock hours of operation, and prior to 4 hours after the beginning of lunch periods for all departments of scheduled operations nor later than 5 the establishment requiring inspection. hours after operations begin. In plants (2) Establishments shall maintain where a company rest break of not less consistent work schedules. Any request than 30 minutes is regularly observed, by an establishment for a change in its approximately midpoint between start work schedule involving changes in the of work and the lunch period, and the workweek or an addition or elimi- inspector is allowed this time to meet nation of shifts shall be submitted to his personal needs, the lunch period the area supervisor at least 2 weeks in may be scheduled as long as 51⁄2 hours advance of the proposed change. Fre- after the beginning of scheduled oper- quent requests for change shall not be ations. approved: Provided, however, Minor de- (c) Official establishments, import- viations from a daily operating sched- ers, and exporters shall be provided in- ule may be approved by the inspector spection service, without charge, up to in charge if such request is received on 8 hours per shift during the basic work- the day preceding the day of change. week subject to the provisions of (3) Requests for inspection service § 381.38: Provided, That any additional outside an approved work schedule shifts meet requirements as deter- shall be made as early in the day as mined by the Administrator or his des- possible for overtime work to be per- ignee. The basic workweek shall con- formed within that same workday; or sist of 5 consecutive 8-hour days within made prior to the end of the day’s oper- the administrative workweek Sunday ation when such a request will result in through Saturday, except that, when overtime service at the start of the fol- possible, the Department shall sched- lowing day: Provided, That an inspector ule the basic workweek so as to consist may be recalled to his assignment after of 5 consecutive 8-hour days Monday the completion of his daily tour of duty through Friday. The 8-hour day ex- under the provisions of § 381.39(b). cludes the lunch period but shall include activities deemed necessary by [40 FR 45800, Oct. 3, 1975, as amended at 40 FR the Agency to fully carry out an in- 50719, Oct. 31, 1975; 41 FR 15401, Apr. 13, 1976; spection program, including the time 48 FR 6893, Feb. 16, 1983; 51 FR 32304, Sept. 11, for FSIS inspection program personnel 1986; 76 FR 33980, June 10, 2011; 77 FR 59294, to put on required gear, pick up re- Sept. 27, 2012] quired forms and walk to a work sta- § 381.38 Overtime and holiday inspection; and the time for FSIS inspection tion service. program personnel to return from a work station, drop off required forms, (a) The management of an official es- and remove required gear; and to con- tablishment, an importer, or an ex- duct duties scheduled by FSIS, includ- porter shall reimburse the Program, at ing administrative duties. The Depart- the rate specified in § 391.3, for the cost ment may depart from the basic work- of the inspection service furnished on week in those cases where maintaining any holiday specified in paragraph (b) such a schedule would seriously handi- of this section; or for more than 8 cap the Department in carrying out its hours on any day, or more than 40 functions. These provisions are applica- hours in any administrative workweek ble to all official establishments except Sunday through Saturday. in certain cases as provided in (b) Holidays for Federal employees § 381.145(h) of this subchapter. shall be New Year’s Day, January 1; (d)(1) Each official establishment Birthday of Martin Luther King, Jr., shall submit a work schedule to the the third Monday in January; Washing- area supervisor for approval. In consid- ton’s Birthday, the third Monday in eration of whether the approval of an February; Memorial Day, the last Mon- establishment work schedule shall be day in May; Independence Day, July 4; given, the area supervisor shall take in Labor Day, the first Monday in Sep- account the efficient and effective use tember; Columbus Day, the second of inspection personnel. The work Monday in October; Veterans’ Day, No- schedule must specify the workweek, vember 11; Thanksgiving Day, the

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fourth Thursday in November; Christ- (a) Policies to encourage early re- mas Day, December 25. When any of porting of symptoms of injuries and ill- the above-listed holidays falls outside nesses, and assurance that it has no the basic workweek, the nearest work- policies or programs in place that day within that week shall be the holi- would discourage the reporting of inju- day. ries and illnesses. (b) Notification to employees of the [40 FR 45801, Oct. 3, 1975, as amended at 43 FR nature and early symptoms of occupa- 51754, Nov. 7, 1978; 50 FR 51513, Dec. 18, 1985; 52 FR 5, Jan. 2, 1987; 53 FR 13398, Apr. 22, 1988; tional illnesses and injuries, in a man- 54 FR 6390, Feb. 10, 1989] ner and language that workers can understand, including by posting in a con- § 381.39 Basis of billing for overtime spicuous place or places where notices and holiday services. to employees are customarily posted, a (a) Each recipient of overtime or hol- copy of the FSIS/OSHA poster encour- iday inspection service, or both, shall aging reporting and describing report- be billed as provided for in § 381.38(a) able signs and symptoms. and at the rate specified in § 391.3, in (c) Monitoring on a regular and rou- increments of quarter hours. For bill- tine basis of injury and illness logs, as ing purposes, 8 or more minutes shall well as nurse or medical office logs, be considered a full quarter hour. Bill- workers’ compensation data, and any ing will be for each quarter hour of other injury or illness information service rendered by each Inspection available. Service employee. § 381.46 Severability. (b) Official establishments, import- ers, or exporters requesting and receiv- Should a court of competent jurisdic- ing the services of an Inspection Serv- tion hold any provision of this part 381, ice employee after he has completed subpart H to be invalid, such action his day’s assignment and left the prem- shall not affect any other provision of ises, or called back to duty during any this part 381. overtime or holiday period, shall be billed for a minimum of 2 hours over- Subpart I—Operating Procedures time or holiday inspection service at the established rate. § 381.65 Operations and procedures, (c) Bills are payable upon receipt and generally. become delinquent 30 days from the (a) Operations and procedures involv- date of the bill. Overtime or holiday in- ing the processing, other handling, or spection will not be performed for any- storing of any poultry product must be one having a delinquent account. strictly in accord with clean and sanitary practices and must be conducted [40 FR 45801, Oct. 3, 1975, as amended at 54 FR 6390, Feb. 10, 1989] in a manner that will result in sanitary processing, proper inspection, and the production of poultry and poultry prod- Subpart H—Attestation on Work- ucts that are not adulterated. Related Conditions (b) Poultry must be slaughtered in accordance with good commercial prac- SOURCE: 79 FR 49634, Aug. 21, 2014, unless tices in a manner that will result in otherwise noted. thorough bleeding of the carcasses and ensure that breathing has stopped prior § 381.45 Attestation requirements. to scalding. Blood from the killing op- Each establishment that participates eration must be confined to a rel- in the New Poultry Inspection System atively small area. (NPIS) shall submit on an annual basis (c) When thawing frozen ready-to- an attestation to the management cook poultry in water, the establish- member of the local FSIS circuit safe- ment must use methods that prevent ty committee stating that it maintains adulteration of, or net weight gain by, a program to monitor and document the poultry. any work-related conditions of estab- (d) The water used in washing the lishment workers, and that the pro- poultry must be permitted to drain gram includes the following elements: freely from the body cavity.

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(e) Detached ova may be collected for (ii) Very low volume establishments human food and handled only in ac- annually slaughter no more than cordance with 9 CFR 590.44 and may 440,000 chickens, 60,000 turkeys, 60,000 leave the establishment only to be ducks, 60,000 geese, 60,000 guineas, or moved to an official egg product proc- 60,000 squabs. essing plant for processing. Ova from (2) Sampling frequency. (i) Establish- condemned carcasses must be con- ments, except for very low volume es- demned and treated as required in tablishments as defined in paragraph § 381.95. (g)(1)(ii) of this section, must, at a (f) Procedures for controlling visible minimum, collect and analyze samples fecal contamination. Official poultry at a frequency proportional to the es- slaughter establishments must develop, tablishment’s volume of production at implement, and maintain written pro- the following rates: cedures to ensure that poultry car- (A) Chickens. Once per 22,000 carcasses contaminated with visible fecal casses, but a minimum of once during material do not enter the chiller. Es- each week of operation. tablishments must incorporate these (B) Turkeys, ducks, geese, guineas, and procedures into their HACCP plans, or squabs. Once per 3,000 carcasses, but at sanitation SOPs, or other prerequisite a minimum once each week of oper- programs. ation. (g) Procedures for controlling contami- (ii) Very low volume establishments nation throughout the slaughter and as defined in paragraph (g)(1)(ii) of this dressing operation. Official poultry section must collect and analyze sam- slaughter establishments must develop, ples at least once during each week of implement, and maintain written pro- operation starting June 1 of every cedures to prevent contamination of year. If, after consecutively collecting carcasses and parts by enteric patho- 13 weekly samples, a very low volume gens and fecal contamination through- establishment can demonstrate that it out the entire slaughter and dressing is effectively maintaining process con- operation. Establishments must incor- trol, it may modify its sampling plan. porate these procedures into their (iii) Establishments must sample at a HACCP plans, or sanitation SOPs, or frequency that is adequate to monitor other prerequisite programs. At a min- their ability to maintain process con- imum, these procedures must include trol for enteric pathogens. Establish- sampling and analysis for microbial or- ments must maintain accurate records ganisms in accordance with the sam- of all test results and retain these pling location and frequency require- records as provided in paragraph (h) of ments in paragraphs (g)(1) and (2) of this section. this section to monitor their ability to (h) Recordkeeping requirements. Offi- maintain process control. cial poultry slaughter establishments (1) Sampling locations. Establish- must maintain daily records sufficient ments, except for very small establish- to document the implementation and ments operating under Traditional In- monitoring of the procedures required spection or very low volume establish- under paragraph (g) of this section. ments operating under Traditional In- Records required by this section may spection must collect and analyze sam- be maintained on computers if the es- ples for microbial organisms at the tablishment implements appropriate pre-chill and post-chill points in the controls to ensure the integrity of the process. Very small establishments op- electronic data. Records required by erating under Traditional Inspection this section must be maintained for at and very low volume establishments least one year and must be accessible operating under Traditional Inspection to FSIS. must collect and analyze samples for [66 FR 1771, Jan. 9, 2001; 66 FR 19714, Apr. 17, microbial organisms at the post-chill 2001, as amended at 79 FR 49634, Aug. 21, 2014] point in the process. (i) Very small establishments are es- § 381.66 Temperatures and chilling tablishments with fewer than 10 em- and freezing procedures. ployees or annual sales of less than $2.5 (a) General. Temperatures and proce- million. dures that are necessary for chilling

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and freezing ready-to-cook poultry, in- practices and procedures must be such cluding all edible portions thereof, as will minimize water absorption and must be in accordance with operating retention at time of packaging. procedures that ensure the prompt re- (2) The establishment must provide moval of the animal heat, preserve the scales, weights, identification devices, condition and wholesomeness of the and other supplies necessary to con- poultry, and assure that the products duct water tests. are not adulterated. (e) Air chilling. Air chilling is the (b) Chilling performance standards, ex- method of chilling raw poultry car- cept for ratites. (1)(i) Each official poul- casses and parts predominately with try slaughter establishment must en- air. An antimicrobial intervention may sure that all poultry carcasses, parts, be applied with water at the beginning and giblets are chilled immediately of the chilling process, provided that after slaughter operations so that its use does not result in any net pick- there is no outgrowth of pathogens, un- up of water or moisture during the less such poultry is to be frozen or chilling process. The initial anti- cooked immediately at the official es- microbial intervention may result in tablishment. some temperature reduction of the (ii) Previously chilled poultry car- product, provided that the majority of casses and major portions must be kept temperature removal is accomplished chilled so that there is no outgrowth of exclusively by chilled air. the pathogens, unless such poultry is (f) Freezing. (1) Ready-to-cook poul- to be packed and frozen immediately at try which is to be or is labeled with de- the official establishment. scriptive terms such as ‘‘fresh frozen,’’ (2) After product has been chilled, the ‘‘quick frozen’’ or ‘‘frozen fresh’’ or any establishment must prevent the out- other term implying a rapid change growth of pathogens on the product as from a fresh state to a frozen state long as the product remains at the es- shall be placed into a freezer within 48 tablishment. hours after initial chilling in accord- (3) The establishment must develop, implement, and maintain written pro- ance with paragraph (b) of this section. cedures for chilling that address, at a During this period, if such poultry is minimum, the potential for pathogen not immediately placed into a freezer outgrowth, the conditions affecting after chilling and packaging, it shall be ° carcass chilling, and when its chilling held at 36 F. or lower. process is completed. The establish- (2) Ready-to-cook poultry shall be ment must incorporate these proce- frozen in a manner so as to bring the dures into its HACCP plan, or sanita- internal temperature of the birds at tion SOP, or other prerequisite pro- the center of the package to 0 °F. or gram. below within 72 hours from the time of (c) Ice and water chilling. (1) Only ice entering the freezer. Such procedures produced from potable water may be shall not apply to raw poultry product used for ice and water chilling, except described in § 381.129(b)(6)(i) of this sub- that water and ice used for chilling chapter. may be reused in accordance with (3) Upon written request, and under § 416.2(g). The ice must be handled and such conditions as may be prescribed stored in a sanitary manner. by the Administrator, in specific cases, (2)(i) Poultry chilling equipment ready-to-cook poultry which is to be must be operated in a manner con- frozen immediately may be moved sistent with meeting the applicable from the official establishment prior to pathogen reduction performance stand- freezing: Provided, That the plant and ards for raw poultry products as set freezer are so located and such nec- forth in § 381.94 and the provisions of essary arrangements are made that the the establishment’s HACCP plan. Inspection Service will have access to (ii) Major portions of poultry car- the freezing room and adequate oppor- casses, as defined in § 381.170(b)(22), may tunity to determine compliance with be chilled in water and ice. the time and temperature require- (d) Water absorption and retention. (1) ments specified in paragraph (f)(2) of Poultry washing, chilling, and draining this section.

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(4) Warm packaged ready-to-cook MAXIMUM PRODUCTION LINE RATES—CHICKENS poultry which is to be chilled by imme- AND SQUABS-TRADITIONAL INSPECTION PRO- diate entry into a freezer within the of- CEDURES ficial establishment shall within 2 Birds hours from time of slaughter be placed Number of in- per in- Line configuration 1 spector in a plate freezer or a freezer with a spection per functioning circulating air system stations minute where a temperature of ¥10 °F. or 6–1 ...... 1 25 lower is maintained. 12–1 ...... 2 23 (5) Frozen poultry shall be held under 12–2 ...... 2 21 18–1 ...... 3 19 conditions which will maintain the 18–2 ...... 3 19 product in a solidly frozen state with 18–3 ...... 3 18 temperature maintained as constant as 24–1 ...... 4 161⁄2 24–2 ...... 4 16 possible under good commercial prac- 24–4 ...... 4 151⁄2 tice. 1 Birds are suspended on the slaughter line at 6–inch intervals. The first number indicates the interval in inches between [37 FR 9706, May 16, 1972, as amended at 39 the birds that each inspector examines. The second number FR 4568, 4569, Feb. 5, 1974; 40 FR 42338, Sept. indicates how many of the birds presented, the inspector is to inspect, i.e., ‘‘1’’ means inspect every bird. ‘‘4’’ means inspect 12, 1975; 49 FR 9411, Mar. 13, 1984; 60 FR 44412, every fourth bird, etc. Aug. 25, 1995; 63 FR 48960, Sept. 11, 1998; 66 FR 1771, Jan. 9, 2001; 66 FR 19714, Apr. 17, 2001; 66 [47 FR 23435, May 28, 1982, as amended at 66 FR 22905, May 7, 2001; 79 FR 49634, Aug. 21, FR 22905, May 7, 2001] 2014] § 381.68 Maximum inspection rates— § 381.67 Young chicken and squab New turkey inspection system. slaughter inspection rate maxi- (a) The maximum inspection rates mums under traditional inspection for one inspector New Turkey Inspec- procedure. tion (NTI–1 and NTI–1 Modified) and The maximum number of birds to be two inspectors New Turkey Inspection inspected by each inspector per minute (NTI–2 and NTI–2 Modified) are listed under the traditional inspection proce- in the table below. The line speeds for dure for the different young chicken NTI–1 and NTI–2 are for lines using and squab slaughter line configurations standard 9-inch shackles on 12-inch are specified in the following table. centers with birds hung on every These maximum rates will not be ex- shackle and opened with J-type or Bar- ceeded. The inspector in charge will be type opening cuts. The line speeds for responsible for reducing production NTI–1 Modified and NTI–2 Modified are line rates where in the inspector’s for Bar-type cut turkey lines using a judgment the prescribed inspection shackle with a 4-inch by 4-inch selector procedure cannot be adequately per- (or kickout), a 45 degree bend of the formed within the time available, ei- lower 2 inches, an extended central loop portion of the shackle that lowers ther because the birds are not pre- the abdominal cavity opening of the sented by the official establishment in carcasses to an angle of 30 degrees from such a manner that the carcasses, in- the vertical in direct alignment with cluding both internal and external sur- the inspector’s view, and a width of 10.5 faces and all organs, are readily acces- inches. Maximum rates for those estab- sible for inspection, or because the lishments having varying configura- health conditions of a particular flock tions will be established by the Admin- dictate a need for a more extended in- istrator but will not exceed those in spection procedure. The standards in the table. Neither the rates in the table 381.170(a) of this part specify which nor those established for establish- classes of birds constitute young chick- ments with varying configurations ens and squabs. Section 381.76(b) speci- shall be exceeded under any cir- fies when either the traditional inspec- cumstances. tion procedure or the modified tradi- (b) There are two categories of tur- tional inspection procedure can or keys for determining inspection rates, must be used. ‘‘light turkeys’’ and ‘‘heavy turkeys’’. Light turkeys are all turkeys weighing

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less than 16 pounds. Heavy turkeys are formed within the time available be- all turkeys weighing 16 pounds or cause the health conditions of a par- more. The weights refer to the bird at ticular flock or other factors, including the point of post-mortem inspection, the manner in which birds are being with blood, feathers and feet removed. presented to the inspector for inspec- (c) The inspector in charge may re- tion and the level of contamination duce inspection line rates when in his/ among the birds on the line, dictate a her judgment the prescribed inspection need for a more extended inspection. procedure cannot be adequately per-

MAXIMUM TURKEY INSPECTION RATES

Birds/minute Line configura- Number of J-Type Bar-Type Inspection system tion inspectors (<16#) (>16#) 1 (<16#) (>16#) 1 light heavy light heavy

NTI–1 ...... 12–1 1 32 30 25 21 NTI–2 ...... 2 24–2 2 51 41 45 35 NTI–1 Modified ...... 12–1 1 — — 32 30 NTI–2 Modified ...... 2 24–2 2 — — 51 41 1 This weight refers to the bird at the point of post-mortem inspection without blood or feet. 2 The turkeys are suspended on the slaughter line at 12-inch intervals with two inspectors each looking at alternating birds at 24-inch intervals.

[50 FR 37512, Sept. 16, 1985, as amended at 73 FR 51902, Sept. 8, 2008]

EDITORIAL NOTE: At 75 FR 27926, May 19, 2010, § 381.68(a) was amended in the second sentence by removing ‘‘10.5’’ and adding in its place ‘‘10’’; however, the amendment could not be incorporated because ‘‘10.5’’ does not exist in that sentence.

§ 381.69 Maximum line speed rates section shall comply with all other ap- under the New Poultry Inspection plicable requirements of the laws, in- System. cluding, but not limited to, 29 U.S.C. (a) The maximum line speed for 654(a). young chicken slaughter establish- [79 FR 49635, Aug. 21, 2014] ments that operate under the New Poultry Inspection System is 140 birds per minute. Subpart J—Ante Mortem (b) The maximum line speed for tur- Inspection key slaughter establishments that operate under the New Poultry Inspec- § 381.70 Ante mortem inspection; when required; extent. tion System is 55 birds per minute. (c) Notwithstanding paragraphs (a) (a) An ante mortem inspection of and (b) of this section, establishments poultry shall, where and to the extent that operate under the New Poultry In- considered necessary by the Adminis- spection System must reduce their line trator and under such instructions as speed as directed by inspectors-in- he may issue from time to time, be charge. Inspectors-in-charge are au- made of poultry on the day of slaugh- thorized to direct establishments to op- ter in any official establishment. erate at a reduced line speed when in (b) The examination and inspection their judgment a carcass-by-carcass in- of ratites will be on the day of slaugh- spection cannot be adequately per- ter, except: formed within the time available due (1) When it is necessary for humane to the manner in which the birds are reasons to slaughter an injured animal presented to the online carcass inspec- at night or on a Sunday or holiday, and tor, the health conditions of a par- the FSIS veterinary medical officer ticular flock, or factors that may indi- cannot be obtained; or cate a loss of process control. (2) In low volume establishments, (d) Establishments operating under when ante mortem inspection cannot the line speed limits authorized in this be done on the day of slaughter, and

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the birds to be slaughtered have re- (f) When it is necessary for humane ceived ante mortem inspection in the reasons to slaughter an injured ratite last 24 hours, provided the establish- at night or Sunday or a holiday, and ment has an identification and control the Agency veterinary medical officer system over birds that have received cannot be obtained, the carcass and all ante mortem inspection. parts shall be kept for inspection, with the head and all viscera except the gas- [37 FR 9706, May 16, 1972, as amended at 66 trointestinal tract held by the natural FR 22906, May 7, 2001] attachment. If all parts are not so kept for inspection, the carcass shall be con- § 381.71 Condemnation on ante mortem inspection. demned. If on inspection of a carcass slaughtered in the absence of an in- (a) Birds plainly showing on ante spector, any lesion or other evidence is mortem inspection any disease or con- found indicating that the bird was sick dition, that under §§ 381.80 to 381.93, in- or diseased, or affected with any other clusive, would cause condemnation of condition requiring condemnation of their carcasses on post mortem inspec- the animal on ante mortem inspection, tion, shall be condemned. Birds which or if there is lacking evidence of the on ante mortem inspection are con- condition that rendered emergency demned shall not be dressed, nor shall slaughter necessary, the carcass shall they be conveyed into any department be condemned. Ratites that are sick, of the official establishment where dying, or that have been treated with a poultry products are prepared or held. drug or chemical and presented for Poultry which has been condemned on slaughter before the required with- ante mortem inspection and has been drawal period, are not covered by emer- killed or died otherwise shall under the gency slaughter provisions. supervision of an inspector of the In- spection Service, be disposed of as pro- [37 FR 9706, May 16, 1972, as amended at 66 vided in § 381.95. FR 22906, May 7, 2001; 67 FR 13258, Mar. 22, 2002] (b) Dead-on-arrival ratites and ratites condemned on ante mortem in- § 381.72 Segregation of suspects on spection will be tagged ‘‘U.S. Con- ante mortem inspection. demned’’ by an establishment em- (a) All birds, except ratites, that on ployee under FSIS supervision and dis- ante mortem inspection do not plainly posed of by one of the methods pre- show, but are suspected of being af- scribed in § 381.95. fected with, any disease or condition (c) All seriously crippled ratites and that under §§ 381.80 to 381.93 of this Part non-ambulatory ratites, commonly may cause condemnation in whole or in termed ‘‘downers,’’ shall be identified part on post mortem inspection, shall as ‘‘U.S. Suspects.’’ be segregated from the other poultry (d) Ratites exhibiting signs of drug or and held for separate slaughter, evis- chemical poisoning shall be withheld ceration, and post mortem inspection. from slaughter. The inspector shall be notified when (e) Ratites identified as ‘‘U.S. Sus- such segregated lots are presented for pects’’ or ‘‘U.S. Condemned’’ may be post mortem inspection, and inspection set aside for treatment. The ‘‘U.S. Sus- of such birds shall be conducted sepa- pect’’ or ‘‘U.S. Condemned’’ identifica- rately. Such procedure for the correlation device will be removed by an es- tion of ante mortem and post mortem tablishment employee under FSIS su- findings by the inspector, as may be pervision following treatment if the prescribed or approved by the Adminis- bird is found to be free of disease. Such trator, shall be carried out. a bird found to have recovered from the (b) All ratites showing symptoms of condition for which it was treated may disease will be segregated, individually be released for slaughter or for pur- tagged as ‘‘U.S. Suspects’’ by establish- poses other than slaughter, provided ment personnel under FSIS supervision that in the latter instance permission with a serially numbered metal or plas- is first obtained from the local, State, tic leg band or tag bearing the term or Federal sanitary official having ju- ‘‘U.S. Suspect,’’ and held for further risdiction over movement of such birds. examination by an FSIS veterinarian.

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Depending upon the findings of the vet- tissues adulterated, they shall, at the erinarian’s examination, these birds option of the operator of the establish- will either be passed for regular slaugh- ment, be processed at the establish- ter, slaughtered as suspects, withheld ment and the carcasses and all parts from slaughter, or condemned on ante thereof retained under U.S. Retained mortem. Those ratites affected with tags, pending final disposition in ac- conditions that would be readily de- cordance with § 381.80, of this part, and tected on post mortem inspection need other provisions in subpart K; or they not be individually tagged on ante shall be slaughtered at the establish- mortem inspection with the ‘‘U.S. Sus- ment and buried or incinerated in a pect’’ tag provided that such ratites are segregated and otherwise handled manner satisfactory to the inspector. as ‘‘U.S. Suspects.’’ All ratites identi- Alternatively, such poultry may be re- fied as ‘‘U.S. Condemned’’ shall be turned to the grower, if further holding tagged by establishment personnel, is likely to result in their not being under FSIS supervision, with a serially adulterated by reason of any residue. numbered metal or plastic leg band or The Inspection Service will notify the tag bearing the term ‘‘U.S. Con- other Federal and State agencies condemned.’’ cerned of such action. To aid in determining the amount of residue present [66 FR 22906, May 7, 2001] in the poultry, officials of the Inspec- § 381.73 Quarantine of diseased poul- tion Service may permit the slaughter try. of any such poultry for the purpose of If live poultry, which is affected by collecting tissues for analysis of the any contagious disease which is trans- residue. Such analysis may include the missible to man, is brought into an of- use of inplant screening procedures de- ficial establishment, such poultry shall signed to detect the presence of anti- be segregated. The slaughtering of such microbial residues in any species of poultry shall be deferred and the poul- poultry. try shall be dealt with in one of the following ways: [47 FR 41336, Sept. 20, 1982] (a) If it is determined by a veterinary inspector that further handling of the § 381.75 Poultry used for research. poultry will not create a health hazard, (a) No poultry used in any research the lot shall be slaughtered separately, investigation involving an experi- subject to ante mortem and post mental biological product, drug, or mortem inspection pursuant to the reg- chemical shall be eligible for slaughter ulations. at an official establishment unless the (b) If it is determined by a veterinary operator of such establishment, the inspector that further handling of the sponsor of the investigation, or the in- poultry will create a health hazard, vestigator has submitted to the Inspec- such poultry may be released for treat- tion Service, or the Veterinary Bio- ment under the control of an appro- logics unit of Veterinary Services, Ani- priate State or Federal agency. If the mal and Plant Health Inspection Serv- circumstances are such that release for ice of the Department or the Environ- treatment is impracticable, a careful mental Protection Agency, or the Food bird-by-bird ante mortem inspection shall be made, and all birds found to and Drug Administration of the De- be, or which are suspected of being, af- partment of Health, Education, and fected with a contagious disease trans- Welfare, data or a summary evaluation missible to man shall be condemned. of the data which demonstrates that the use of such biological product, § 381.74 Poultry suspected of having drug, or chemical will not result in the biological residues. products of such poultry being adulter- When any poultry at an official es- ated, and the Administrator has ap- tablishment is suspected of having proved such slaughter. been treated with or exposed to any [37 FR 9706, May 16, 1972, as amended at 39 substance that may impart a biological FR 4569, Feb. 5, 1974] residue that would make their edible

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Subpart K—Post Mortem Inspec- (a) The operator requests it, and tion; Disposition of Carcasses (b) The Administrator determines and Parts that the establishment meets all the facility requirements in § 381.36(e). § 381.76 Post-mortem inspection under (iv) The NPIS may be used for young Traditional Inspection, the Stream- chickens and turkeys if the official es- lined Inspection System (SIS), the tablishment requests to use it and New Line Speed (NELS) Inspection meets or agrees to meet the require- System, the New Poultry Inspection ments of paragraph (b)(6) of this sec- System (NPIS), the New Turkey In- spection System (NTI), and Ratite tion and the Administrator approves Inspection. the establishment’s request. The Ad- ministrator may permit establish- (a) A post-mortem inspection shall be ments that slaughter classes of poultry made on a bird-by-bird basis on all other than young chickens and turkeys poultry eviscerated in every official es- to operate under the New Poultry In- tablishment. Each carcass, or all parts spection System under a waiver from comprising such carcass, must be ex- the provisions of the regulations as amined by an inspector, except for provided in § 381.3(b). parts that are not needed for inspection purposes and are not intended for (v) Traditional Inspection shall be human food and are condemned. Each used for turkeys when neither the NTI carcass eviscerated shall be prepared as System nor the NPIS is used. For other ready-to-cook poultry. classes of poultry, Traditional Inspec- tion shall be used when SIS, NELS, and (b)(1) There are six systems of post- the NPIS are not used. mortem inspection: the New Poultry Inspection System (NPIS), which may (2) Official establishments that oper- be used for young chickens and tur- ate under Traditional Inspection, SIS, keys; the Streamlined Inspection Sys- NELS, NTI, or Ratite Inspection must tem (SIS) and the New Line Speed In- meet the following requirements: spection System (NELS), both of which (i) No viscera or any part thereof may be used only for broilers and cor- may be removed from any poultry nish game hens; the New Turkey In- processed in any official establishment, spection (NTI) System, which may be except at the time of post-mortem in- used only for turkeys; Traditional In- spection, unless its identity with the spection, which may be used for all rest of the carcass is maintained in a poultry, except for ratites; and Ratite manner satisfactory to the inspector Inspection. until such inspection is made. (i) The SIS shall be used only for (ii) Each carcass to be eviscerated broilers and cornish game hens if: must be opened so as to expose the or- (a) The Administrator determines gans and the body cavity for proper ex- that SIS will increase inspector effi- amination by the inspector. ciency; or (iii) If a carcass is frozen, it must be (b) The operator requests SIS and the thoroughly thawed before being opened Administrator determines that the sys- for examination by an inspector. tem will result in no loss of inspection (3) The following requirements are efficiency. applicable to SIS: (ii) The NELS Inspection System (i) Definitions. For purposes of this shall be used only for broilers and cor- paragraph, the following definitions nish game hens if: shall apply: (a) The operator requests the NELS (a) Cumulative sum (CUSUM). A sta- Inspection System, and tistical concept used by the establish- (b) The Administrator determines ment and monitored by the inspector that the establishment has the intent whereby compliance is determined and capability to operate at line speeds based on sample results collected over greater than 70 birds per minute, and a period of time. For purposes of deter- meets all the facility requirements in mining compliance with the finished § 381.36(d). product standards, the CUSUM is equal (iii) The NTI System shall be used to the sum of prior test results plus the only for turkeys if: weighted result of the current test

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minus the tolerance, with the condi- ment provide one inspection station for tion that the resulting CUSUM cannot each line and adequate reinspection fa- go below zero. cilities so carcasses can be removed (b) Tolerance number. A weighted from each line for evaluation. The measure that equates to product being maximum line speed for SIS–1 is 35 produced at a national product quality birds per minute. SIS–2 requires that level. See Table 2. the establishment provide two inspec- (c) Action number. A level reached by tion stations for each line and ade- the CUSUM where the process is out of quate reinspection facilities so car- control and product action is required casses can be removed from each line by the establishment or the inspector. for evaluation. The maximum line See Table 2. speed for SIS–2 is 70 birds per minute. (d) ‘‘Start number’’. A value halfway (c) Under all inspection systems, in- between zero and the action number. cluding SIS, inspectors conduct post- The start number is used to determine mortem inspection and look for a num- the starting CUSUM for the first sub- ber of conditions, as specified else- group of a shift and to reset the where in this subpart, which may indi- CUSUM value if the CUSUM is equal to cate adulteration. Adulterated product or greater than the action number. See is condemned and destroyed, except Table 2. that carcasses and parts which may be (e) Subgroup. A 10-bird sample col- made unadulterated by reprocessing lected before product enters the chiller (reworking) may be so reprocessed and after product leaves the chiller. under the supervision of an inspector (f) Subgroup absolute limit. The toler- and reinspected. Under SIS, inspectors ance number plus 5. See Table 2. also reinspect product by sampling fin- (g) Prechill testing. Testing conducted ished birds (both before and after by the establishment to determine the chilling) for nonconformances with fin- CUSUM on consecutive 10-bird sub- ished product standards (see Table 1). If group samples collected prior to prod- such nonconformances are present at uct entering the chilling system. certain statistical levels, it may indi- (h) Postchill testing. Testing con- cate process difficulties requiring cor- ducted by the establishment to deter- rective action by the establishment. If mine the CUSUM on consecutive 10- the establishment does not take ade- bird subgroup samples collected as the quate corrective action, the inspector product leaves the chilling system. shall initiate corrective actions such as (i) Rework. Reprocessing the product conducting closer post-mortem inspec- to correct the condition or conditions tions and requiring reprocessing and causing the nonconformances listed in reinspection of previously processed Table 1. carcasses and parts. Thus, SIS is con- (ii) General. (a) Under SIS, one in- ducted in two phases—a post-mortem spector inspects the outside, inside, inspection phase and a reinspection and viscera of each bird. There may be phase. The following paragraphs de- two inspectors on one processing line, scribe the inspection requirements (not each inspecting every other bird. For addressed elsewhere in this subpart) the establishment to run its processing under each. line(s) at maximum speed, optimal con- (iii) Post-mortem inspection. (a) Facili- ditions must be maintained so that in- ties: Each inspection station must spection may be conducted efficiently. comply with the facility requirements The inspector in charge determines the in § 381.36(c). speed at which each processing line (b) Presentation: Each inspector shall may be operated to permit inspection. be flanked by an establishment em- A variety of conditions may affect this ployee assigned to be the inspector’s determination including the health of helper. The one inspector on the SIS–1 each flock and the manner in which line shall be presented every bird. Each birds are being presented to the inspec- inspector on the SIS–2 line shall be pre- tor for inspection. sented every other bird on the line. An (b) SIS may be performed by one in- establishment employee shall present spector (SIS–1) or two inspectors (SIS– each bird to the inspector properly 2). SIS–1 requires that the establish- eviscerated with the back side toward

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the inspector and the viscera uniformly (5) Hangback racks designed to hold trailing or leading. Each inspector 10 carcasses shall be provided for and shall inspect the inside, viscera, and positioned within easy reach of the per- outside of all birds presented. son at the station. (c) Disposition: The inspector shall (b) Disposition: An inspector shall determine which birds shall be monitor the establishment’s applica- salvaged, reprocessed, condemned, re- tion of the Finished Product Standards tained for disposition by the veteri- program and shall take corrective ac- narian, or allowed to proceed down the tion including retaining product to pre- line as a passed bird subject to trim vent adulterated product from leaving and reinspection. Carcasses with cer- the establishment when the inspector tain defects not requiring condemna- determines that the establishment has tion of the entire carcass shall be failed to apply the program as pre- passed by the inspector, but shall be scribed in paragraph (b)(3)(iv)(c) of this subject to reinspection to ensure the section). physical removal of the defects. The (c) Finished Product Standards: Fin- helper, under the supervision of the in- ished Product Standards (FPS) are cri- spector, shall mark such carcasses for teria applied to processed birds before trim when the defects are not readily and after chill to ensure that the prod- observable. Trimming of birds passed uct being produced is consistently subject to reinspection shall be per- wholesome and unadulterated. These formed by: criteria consist of nonconformances (1) The helper, time permitting, and (listed in Table 1), the incidence of (2) One or more plant trimmers posi- which is determined from 10 bird sub- tioned after all giblets are harvested group samples, reduced to a CUSUM and prior to reinspection. number, and measured against the (iv) Reinspection. (a) Facilities: Rein- standards (Table 2). The standards are spection stations are required at both applied to permit the Agency to esti- the prechill and postchill locations. mate when the production process is in The Agency will determine the number control and when it is out of control. of stations needed in those establish- The establishment is responsible for ments having more than one processing maintaining FPS which, in turn, is line or more than one chiller. One or monitored by the inspector. FPS is ap- more prechill reinspection stations plied in two separate parts. The first is shall be conveniently located at the called prechill testing. It is designed to end of the line or lines prior to ensure that the slaughter and eviscera- chilling. One or more postchill stations tion procedures are in control. Compli- must be conveniently located at the ance is measured by determining the end of the chiller or chillers. The CUSUM on consecutive 10-bird sub- prechill and postchill reinspection sta- group samples collected prior to prod- tions must meet the following provi- uct entering the chilling system. The sions: second part of the FPS is called (1) Floor space shall consist of 3 feet postchill testing. It is designed to mon- along each conveyor line. The space itor the production through the chill shall be level and protected from all system to ensure that it meets the traffic and overhead obstructions. postchill FPS. This test is independent (2) A table at least 2 feet wide and 2 of the prechill test. Compliance is feet deep and 3 feet in height designed measured by determining the CUSUM to be readily cleanable and drainable on consecutive 10-bird subgroup sam- shall be provided for reinspecting the ples as they exit the chilling system. sampled birds. When the system is operating within (3) A minimum of 200 foot-candles of compliance, the establishment applies shadow-free lighting with a minimum the FPS to product samples at the color rendering index of 85 on the table prechill reinspection station. Testing surface. time and time between tests are such (4) A separate clip board holder shall that birds represented by the test are be provided for holding the recording still within the chiller. If an out-of- sheets. compliance condition is found, the

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product leaving the chiller is seg- shift on the evisceration line. In estab- regated for rework and retested before lishments that have multiple eviscera- it may proceed into commerce. A section lines on a production shift, mon- ond 10 bird subgroup sample of the itor all lines of product at the random birds is taken after they leave the times. chiller to ensure that the product (B) Collect the subgroup samples to meets the postchill FPS. Since the be monitored at preselected times. All product is closer to the end of proc- 10 samples of the subgroup shall be col- essing, the controls on releasing re- lected at the random time selected in worked product are stricter than con- paragraph (b)(3)(iv)(d)(1)(ii)(A) of this trols under prechill testing, again to section. ensure that no adulterated product en- (C) Conduct the 10-bird monitoring ters into commerce. subgroup test. (d) Prechill testing. The prechill FPS (2) Actions to be taken when the sub- have been divided into processing and group absolute limit is exceeded. If either trim categories. The processing cat- an inspector or establishment subgroup egory is designed to monitor the out- test exceeds the subgroup absolute put of the dressing and evisceration limit of tolerance plus 5 (T+5), the es- procedures. The trim category mon- tablishment shall determine if any of itors the establishment’s ability to re- the immediate past 5 plant prechill move unwholesome lesions and condi- subgroups for that category (processing tions from inspected and passed car- or trim) resulted in a CUSUM above casses. Each category is monitored the start number. independently of the other category using a separate CUSUM for each cat- (i) If all of the past 5 plant prechill egory. subgroups are at or below the start (1) Actions to be taken when the process number, the establishment shall imme- is in control. If the CUSUM is less than diately conduct a retest subgroup on the action number and the subgroup that category of prechill to determine absolute limit is not exceeded, the sample validity. If retest subgroup process is judged to be in control. total equals tolerance or less, the es- (i) Establishment Actions. The estab- tablishment resumes random time test- lishment shall: ing. If the retest subgroup total ex- (A) Randomly select and record sub- ceeds tolerance, the establishment group sampling times for each produc- shall proceed as if CUSUM reaches the tion unit of time before product action number and shall begin process reaches the prechill reinspection sta- actions as set forth in paragraph tion on the production line. In no case (b)(3)(iv)(d)(4) of this section. In either shall the time between tests exceed 1 case, the prechill retest results will be hour of production time. used to calculate CUSUM. (B) Conduct a 10-bird subgroup test (ii) If any of the past 5 plant prechill at a random time on each poultry subgroups resulted in a CUSUM above slaughter line. These times are the start number, the establishment preselected by the establishment and shall proceed as if CUSUM reaches the available to the inspector prior to the action number and shall begin process start of the shift/day’s operations. All actions as set forth in paragraph 10 samples of the subgroup shall be col- (b)(3)(iv)(d)(4) of this section. lected at the random time. (3) Actions to be taken when a (C) Obtain the weighted value of each trimmable lesion/condition is found. If ei- nonconformance by multiplying the ther inspection or plant monitoring number recorded for each nonconform- finds any trimmable lesion or condi- ance by the ‘‘factor’’ in Table 1, sum tion as specified in item B(7) of Table 1 the total of all the nonconformances, during a prechill subgroup test, the es- and calculate the CUSUM value for tablishment shall immediately conduct that test. an additional prechill subgroup test for (ii) Inspector Actions. The inspector the same trimmable lesion/condition shall: category. This is a requirement on the (A) Select random times for moni- subgroup testing for the prechill trim toring subgroup tests for each half- nonconformance that is in addition to

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the CUSUM test described in paragraph the production supervisor. The number (b)(3)(iv)(d)(1) of this section. of additional tests at the postchill rein- (i) If no additional item in the same spection station using prechill stand- category is found on retest, the estab- ards is increased as required to include lishment shall resume random time the product in the chiller represented sampling. by this additional prechill test. (ii) If an additional item in the same (E) After two consecutive additional category is found on retest, the estab- prechill subgroup tests result in sub- lishment shall proceed as if CUSUM group totals equal to or less than toler- reaches the action number and shall ance: initiate corrective action set forth in —Resume random time prechill subparagraph (b)(3)(iv)(d)(4) of this section group testing as set forth in actions to for this category only. be taken when the process is in control (4) Actions to be taken when the at paragraph (b)(3)(iv)(d)(1) of this sec- CUSUM reaches the action number. Once tion. CUSUM reaches the action number, the —Identify product entering the chill process is judged to be not in control. system that will mark the end of the (i) Establishment Actions. The estab- retest action upon arrival at the lishment shall: postchill sampling location. Such iden- (A) Immediately notify the inspector tification may include tagging or in charge and the production super- empty space in chillers, depending visor responsible for the affected evis- upon the establishment’s identification ceration line. method. (B) Suspend random time prechill —Once all product identified as need- testing of the affected nonconformance ing retesting has arrived at the category (processing or trim). Suspend postchill sampling location, random random time postchill subgroup testing time postchill FPS testing resumes. when the processing category is the af- —If two consecutive additional fected nonconformance category. prechill subgroup tests demonstrate (C) Conduct subgroup retests on car- process control with subgroup totals casses leaving the chill system. Apply equal to or less than tolerance, but the prechill criteria in Table 1 (A) or they do not cause CUSUM to fall to the (B), depending upon which category start line or below, reset CUSUM at caused the action, and apply prechill the start number. Finished Product Standards as listed in (ii) Inspector Actions. The inspector Table 2 to determine product compli- shall monitor product and process ac- ance. In no case shall the time between tions by making spot-check observa- retests exceed 30 minutes of production tions to ensure that all program re- time. Apply prechill standard criteria quirements are met. at the postchill location after notifying (e) Postchill testing. Postchill sub- the establishment’s production super- groups shall be collected after the visor. If any of these subgroup retests product leaves the chiller but before on product leaving the chill system re- the product is divided into separate sult in a subgroup total exceeding tol- processes. Each bird sampled shall be erance, identify for rework subsequent observed and its conformance measured product at the postchill location. All against the postchill criteria. The sub- noncomplying product will be brought group nonconformance weights shall be into compliance prior to release into totaled and the CUSUM calculated by commerce. Product from the chiller subtracting the tolerance from the sum will continue accumulating for rework of the subgroup total and the starting until a subsequent subgroup test re- CUSUM. sults in a subgroup total equal to or (1) Actions to be taken when the process less than tolerance. is in control. If the CUSUM is less than (D) Conduct additional subgroup the action number and the subgroup tests at the prechill reinspection sta- absolute limit is not exceeded, the tion to determine the adequacy of pro- process is judged to be in control. duction corrective action. If the (i) Establishment Actions. The estab- prechill tests results in a subgroup lishment shall conduct a 10-bird sub- total exceeding the tolerance, notify group test for each chiller system at a

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randomly selected time of production. (D) After two consecutive additional In no case shall the time between tests postchill subgroup tests results in sub- exceed 2 hours of production time. group totals equal to or less than toler- (ii) Inspector Actions. The inspector ance: shall: —Resume random time postchill sub- (A) Select random times for postchill group testing as set forth in actions to monitoring. be taken when the process is in control (B) Monitor each chill system twice at paragraph (b)(3)(iv)(e)(1) of this sec- per shift. tion. (C) Conduct subgroup tests at —If the two consecutive additional preselected random times. postchill subgroup totals equal to or less than tolerance do not cause (2) Actions to be taken when the sub- CUSUM to fall to the start number or group absolute limit is exceeded. If either below, reset CUSUM at the start num- an inspector or establishment subgroup ber. test exceeds the subgroup absolute ( ) Inspector Actions. The inspector limit of tolerance plus 5(T+5), the es- ii shall monitor product and process ac- tablishment shall determine if any of tions to ensure that program require- the last 5 postchill monitoring sub- ments are met. groups resulted in a CUSUM above the (v) When the prechill or postchill start number. product has been identified as having (i) If all of the past 5 postchill moni- been produced when the process was toring subgroups resulted in a CUSUM not in control, additional online sub- at or below the start number, the es- group testing by the establishment is tablishment shall immediately retest a required to determine its conformance subgroup to determine sample validity. to the standard. If any of the addi- If this retest subgroup total exceeds tional plant subgroup testing results in tolerance, the establishment shall pro- a subgroup total exceeding tolerance, ceed as if CUSUM reaches the action offline product corrective actions must number and shall begin process actions take place. The responsibilities of the as set forth in paragraph (b)(3)(iv)(e)(3) establishment and the inspector of this section. change depending on the CUSUM. (ii) If any of the past 5 postchill mon- All corrective actions such as identi- itoring subgroups resulted in a CUSUM fying affected product, segregating above the start number, the establish- product, and maintaining control ment shall proceed as if CUSUM through rework actions are the estab- reaches the action number and shall lishment’s responsibility. Corrective begin process actions as set forth in actions by the inspector depends upon paragraph (b)(3)(iv)(e)(3) of this section. the establishment’s ability to control (3) Actions to be taken when the rework of affected product. If the es- CUSUM reaches the action number. Once tablishment fails in its responsibilities, CUSUM reaches the action number, the the inspector will identify, segregate, process is judged to be not in control. and retain affected product to prevent (i) Establishment Actions. The estab- adulterated product from reaching con- lishment shall: sumers. (A) Notify the inspector in charge (a) Offline product. The establish- and the production supervisor respon- ment shall identify the affected prod- sible for product in the chiller. uct so that it may be segregated and (B) Suspend random time postchill accumulated offline for rework. The in- subgroup testing. spector shall spot check the establish- (C) Immediately conduct an addi- ment’s identification, segregation, and tional postchill subgroup test. If the control of reworked product to ensure retest subgroup total exceeds toler- that program requirements are met. ance, the establishment shall identify (b) Reworked product. Reworked subsequent product for rework. Prod- product must be tested by the estab- uct will continue accumulating for re- lishment with a randomly selected sub- work until a subsequent subgroup test group test of the accumulated re- results in a subgroup total equal to or worked lot. Before product is released, less than tolerance. the random subgroup test must result

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in a subgroup total equal to or less TABLE 1—DEFINITIONS OF NONCONFORMANCES— than tolerance. If the subgroup test of Continued a reworked lot results in a subgroup —Factor is two. total exceeding tolerance, the lot must —A maximum of two incidents per carcass. be reworked again before another sub- 4 Oil glands remnant—less than two whole group is selected. The following actions glands are required. —Recognizable fragment(s) of one or (1) Establishment Actions. The estab- both oil glands equals one inci- lishment shall: dent. (i) Select the random subgroup from —Factor is one. throughout the lot only after the total —Maximum of one incident per car- lot has been reworked. cass. (ii) Conduct the subgroup test using 5 Oil glands—two whole glands the same criteria (prechill or postchill) —Both whole oil glands with no missing fragments equals one inci- that resulted in the rework action. dent. If the oil glands are cut, but (iii) Release the lot if the reworked no fragment is removed, consider subgroup test resulted in a subgroup them to be whole. But if even a total equal to or less than tolerance. small fragment is removed, use (iv) Identify and control the lot to be line 4. reworked if the reworked subgroup —Factor is two. total again exceeds tolerance. —A maximum of one incident per (2) Inspector Actions: The inspector carcass. 6 Lung ≥1⁄4″ whole shall spot check the rework procedure —Any portion less than a whole to ensure that plant monitoring and lung, and equal to or greater than production meet the requirements of 1⁄4″ at the greatest dimension, the program. equals one incident. (vi) After the 10 bird subgroup tests —Factor is one. are completed, the prechill and —A maximum of two incidents per postchill processing nonconformances carcass. shall be corrected on all bird samples 7 Lung—whole prior to returning the samples to the —Each whole lung equals one incident. product flow. Samples with trim —Factor is two. nonconformances shall be returned to —A maximum of two incidents per the trim station for correction prior to carcass. their return to the product flow. 8 Intestine —Any identifiable portion of the TABLE 1—DEFINITIONS OF NONCONFORMANCES terminal portion of the intestinal A Processing Nonconformances tract with a lumen (closed circle) 1 Extraneous material ≤1⁄16″ present, or split piece of intestine —Include any specks, tiny smears, large enough to be closed to form or stains of material that measure a lumen. 1⁄16″ or less in the greatest dimen- —Factor is five. sion. —A maximum of one incident per Examples: Ingesta, unattached carcass. feathers, grease, bile remnants, 9 Cloaca and/or whole gall bladder or —Any identifiable portion of the spleen, embryonic yolk, etc. terminal portion of the intestinal —Factor is one. tract with mucosal lining. —1 to 5=1 defect: 6 to 10=2 defects; 11 —Factor is five. or more=3 defects. A maximum of —A maximum of one incident per three incidents per carcass. carcass. 2 Extraneous material >1⁄16″ to 1″ 10 Bursa of Fabricius —The same material as line 1, but —A whole rosebud, or identifiable measuring >1⁄16″ to 1″ in the long- portion with two or more mucosal est dimension. folds. —Factor is one. —Factor is two. —A maximum of three incidents per —A maximum of one incident per carcass. carcass. 3 Extraneous material >1″ 11 Esophagus —The same material as lines 1 to 2, —Any portion of the esophagus with but measuring greater than one identifiable mocosal lining. inch. —Factor is two. 460

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TABLE 1—DEFINITIONS OF NONCONFORMANCES— TABLE 1—DEFINITIONS OF NONCONFORMANCES— Continued Continued —A maximum of one incident per B Trim nonconformances carcass. 1 Breast blister 12 Crop—partial—with mucosa —Inflammatory tissue, fluid, or pus —Any portion of the crop that in- between the skin and keel must be cludes the mucosal lining. trimmed if membrane ‘‘slips’’ or if —Factor is two. firm nodule is greater than 1⁄2″ in —A maximum of one incident per diameter (dime size). carcass. —Factor is two. 13 Crop—whole —A maximum of one incident per —Any complete crop. carcass. —Factor is five. 2 Breast blister—partially trimmed —A maximum of one incident per —All inflammatory tissue, including carcass. that which adheres tightly to the 14 Trachea ≤1″ keel bone, must be removed. —Identifiable portion of trachea less —Factor is two. than or equal to one inch long. —A maximum of one incident per —Factor is one. carcass. —A maximum of one incident per 3 Bruise 1⁄2″ to 1″ carcass. —Blood clumps or clots in the su- 15 Trachea >1″ perficial layers of tissue, skin, —Identifiable portion of trachea muscle or loose subcutaneous tis- greater than one inch. sue may be slit and the blood completely washed out. When the —Factor is two. bruise extends into the deeper lay- —A maximum of one incident per ers of muscle, the affected tissue carcass. must be removed. Very small 16 Hair ≥1⁄4″ 26 or more. bruises less than 1⁄2″ (dime size) —Hair which is one-fourth inch long and areas showing only slight red- or longer measured from the top dening need not be counted as de- of the follicle to the end of the fects. hair. 26 or more hairs equal one —Factor is one. incident. —A maximum of five incidents per —Factor is one. carcass. —A maximum of one incident per 4 Bruise >1″ carcass. —Same criteria as in line three, but 17 Feather and/or Pinfeathers ≤1″ greater than one inch in greatest —Attached feathers or protruding dimension. pinfeathers less than or equal to —Factor is two. one inch long. Scored 5 to 10 per —A maximum of three incidents per carcass as one incident, 11 to 15 carcass. per carcass as two incidents, and 5 Bruise black/green 1⁄4″ to 1″ 16 or more as three incidents. —Bruises 1⁄4″ to 1″ that have changed —Factor is one. from red to a black/blue or green —A maximum of three incidents per color due to age. carcass. —Factor is two. 18 Feathers >1″ —A maximum of three incidents per —Attached feathers longer than one carcass. inch. Scored 1 to 3 per carcass as 6 Bruise Black/green >1″ one incident 4 to 6 per carcass as two incidents, and 7 or more as —Same as line 5, but measuring ″ three incidents. greater that 1 in greatest dimension. —Factor is one. —Factor is five. —A maximum of three incidents per carcass. —A maximum of two incidents per carcass. 19 Long Shank—both condyles covered 7 Trimmable lesions/Condition —If the complete tibiotarsal joint is covered, it equals one incident. —A trimmable tumor or identifiable portion of a tumor on any part of —Factor is two. the carcass. —A maximum of two incidents per —Trimmable Synovitis/airsacculitis carcass. (saddle/frog) lesions that have not been removed.

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TABLE 1—DEFINITIONS OF NONCONFORMANCES— TABLE 1—DEFINITIONS OF NONCONFORMANCES— Continued Continued —Lesion/condition subject to re- 11 Untrimmed short hock moval following an approved —When no cartilage of the hock sur- cleanout process. Examples: face is present and no tendons are airsacculitis, salpingitis, nephri- attached to the bone. tis, spleen, or liver conditions re- —Factor is two. quiring removal of the kidneys. —A maximum of two incidents per Note: All establishments shall develop and carcass. maintain a permanent marking system 12 Sores, scabs, inflammatory process, etc. that identifies carcasses with removable ≤1⁄2″ lesions/conditions on the inside surfaces. —Any defects such as sores, ab- When removable lesions/conditions are scesses, scabs, wounds, dermatitis, identified inside the carcass by the in- inflammatory process, that meas- spector, the helper will be notified to ure less than or equal to 1⁄2″ in the apply the permanent mark. When remov- greatest dimension. able inside lesions/conditions are found on —Factor is two. a subgroup sample without the permanent —A maximum of two incidents per mark, the error is not recorded in line 7. carcass. The affected carcass(s) will be hungback 13 Sores, scabs, inflammatory process, etc. for IIC disposition and corrective action. >1⁄2″ —Factor is five. —Same as line 12, but greatest di- —A maximum of one incident per mension is greater than 1⁄2″, or a carcass. cluster of smaller lesions in close 8 Failure to complete task as indicated by proximity >1⁄2″, this category also marking system. includes turkey leg edema. Example: Synovitis, airsacculitis, —Factor is five. inflammatory process, contamina- —A maximum of one incident per tion, etc. carcass. —The helper, under the inspector’s 14 External mutilation direction, will apply a mark to the —Mutilation to the skin and/or mus- carcass, indicating to the trim- cle that is caused by the slaugh- mer(s) that specific action must ter, dressing or eviscerating proc- be taken on that carcass. When esses. Skinned elbows (bucked airsac and kidney cleanout, or wings) do not trim require unless synovitis part removal, or carcass affected wing joint capsule is also removal from the line is not com- opened. pleted, or only partially com- —Factor is one. pleted, this occurrence is recorded —A maximum of three incidents per as one defect. carcass. —Factor is five. It will also be re- C Postchill nonconformances—(Designed corded as a line 7 defect for a total to monitor those nonconformances added factor of 10. to product during the chilling process) —A maximum of one incident per 1 Extraneous material ≤1⁄16″ carcass. —Include specks, grease, or uniden- 9 Compound fracture tifiable foreign material that —Any bone fracture (i.e., leg or measure 1⁄16″ or less in the greatest wing) that has caused an opening dimension. through the skin. May be accom- —Example: Ingesta, grease, or un- panied with a bruise, but not al- identifiable foreign material. ways. Do not count the bruise in —Factor is one. line 3 or 4 if it is associated with —3 to 7=1 defect; 8 to 12=2 defects; 13 the compound fracture. or more=3 defects. A maximum of —Factor is two. three incidents per carcass. —A maximum of three incidents per 2 Extraneous material >1⁄16″ to 1″ carcass. —This includes ingesta, grease, or 10 Wingtip compound fracture unidentifiable foreign material —Same criteria as line 9, but only measureing >1⁄16″ to 1″ longest di- for wingtips. mension. Note: Bruises not associated —Factor is one. with the fracture should be re- —A maximum of three incidents per corded in the appropriate carcass. lines. 3 Extraneous material >1″ —Factor is one. —The same material as line 2, but —A maximum of two incidents per measuring greater than one inch. carcass. —Factor is two. 462

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TABLE 1—DEFINITIONS OF NONCONFORMANCES— (2) One or more plant trimmers posi- Continued tioned after giblet harvest and prior to —A maximum of two incidents per reinspection. carcass. (b) A reinspection station shall be lo- TABLE 2—FINISHED PRODUCT STANDARDS cated at the end of each line. This station shall comply with the facility re- SIS quirements in § 381.36(d)(2). The inspec- Prechill Processing Nonconformance tor shall ensure that the establishment Tolerance number (T) ...... 25 has performed the indicated trimming Subgroup Absolute Limit (T+5) 30 of carcasses passed subject to reinspec- Action number ...... 22 tion by visually monitoring, checking Start number ...... 11 data, or gathering samples at the sta- Prechill Trim Nonconformance tion or at other critical points on the Tolerance number (T) ...... 12 line. Subgroup Absolute Limit (T+5) 17 (ii)–(iii) [Reserved] Action number ...... 15 Start number ...... 8 (iv) The maximum inspection rate for Postchill Nonconformance NELS shall be 91 birds per minute per Tolerance number (T) ...... 5 eviscerating line. Subgroup Absolute Limit (T+5) 10 (5) The following requirements are Action number ...... 10 also applicable to the NTI System: Start number ...... 5 (i) Inspection under the NTI System (4) The following requirements are is conducted in two phases, a post- also applicable to NELS inspection: mortem inspection phase and a rein- (i) Inspection under NELS is con- spection phase. The NTI–1 Inspection ducted in two phases, as post-mortem System requires that the establish- inspection phase and a reinspection ment provide one inspection station for phase. each line and adequate reinspection (a) Post-mortem inspection. The estab- facilitiates so carcasses can be re- lishment shall provide three inspection moved from each line for evaluation. stations on each eviscerating line in The NTI–2 Inspection System requires compliance with the facility require- that the establishment provide two in- ments § 381.36(d)(1). The three inspec- spection stations for each line and ade- tors shall inspect the inside, viscera, quate reinspection facilities so car- and outside of all birds presented. Each casses can be removed from each line inspector shall be flanked by two es- for evaluation. tablishment employees—the presenter (a) Post-mortem inspection. Each in- and the helper. The presenter shall en- spection station must comply with the sure that the bird is properly evis- facility requirements in § 381.36(e)(1). cerated and presented for inspection Each inspector shall be flanked by and and the viscera uniformly trailing or establishment employee assigned to be leading. The inspector shall determine the inspector’s helper. The one inspec- which birds shall be salvaged, reprocessed, condemned, retained for disposi- tor on an NTI–1 Inspection System tion by the veterinarian, or allowed to shall be presented every bird. Each in- proceed down the line as a passed bird spector on an NTI–2 Inspection System subject to reinspection. Poultry car- line shall be presented every other bird casses with certain defects not requir- on the line. An establishment employee ing condemnation of the entire carcass shall present each bird to the inspector shall be passed by the inspector, but properly eviscerated with the back side shall be subject to reinspection to en- toward the inspector and the viscera sure the physical removal of the speci- uniformly trailing or leading. Each in- fied defects. The helper, under the su- spector shall inspect the inside, pervision of the inspector, shall mark viscera, and outside of all birds pre- such carcasses for trim when the de- sented. The inspector shall determine fects are not readily observable. Trim- which bird shall be salvaged, reproc- ming or birds passed subject to rein- essed, condemned, retained for disposi- spection shall be performed by: tion by a veterinarian, or allowed to (1) The helper, time permitting, and proceed down the line as a passed bird 463

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subject to reinspection. Turkey car- and toxemic conditions do not enter casses with certain defects not requir- the chiller. The establishment must in- ing condemnation of the entire carcass corporate these procedures into its shall be passed by the inspector, but HACCP plan, or sanitation SOP, or shall be subject to reinspection to en- other prerequisite program. These pro- sure the physical removal of the speci- cedures must cover, at a minimum, es- fied defects. The helper, under the su- tablishment sorting activities required pervision of the inspector, shall mark under paragraph (b)(6)(ii) of this sec- such carcasses for trim when the de- tion. fects of birds passed subject to rein- (D) The establishment must maintain spection shall be performed by: records to document that the products (1) The helper, time permitting, and resulting from its slaughter operation (2) One or more plant trimmers positioned after the giblet harvest and meet the definition of ready-to-cook prior to reinspection. poultry in § 381.1. These records are (b) Reinspection. A reinspection sta- subject to review and evaluation by tion shall be located at the end of the FSIS personnel. lines. This station shall comply with (iii) Presentation for online carcass in- the facility requirements in spection. To ensure the online carcass § 381.36(e)(2). The inspector shall ensure inspector may properly inspect every that establishments have performed carcass, the establishment must the indicated trimming of each carcass present carcasses as follows: passed subject to reinspection by vis- (A) Each carcass, except carcasses ually monitoring, checking data, and/ and parts identified as ‘‘major por- or sampling product at the reinspections’’ under 9 CFR 381.179(b)(22), must tion station and, if necessary, at other be held by a single shackle; points, critical to the wholesomeness (B) Both hocks of each carcass must of product, on the eviscerating line. be held by the shackle; (ii)–(iii) [Reserved] (C) The back side of the carcass must (6) The following requirements are be faced toward the inspector; applicable to the NPIS: (D) There must be minimal carcass (i) Facilities. The establishment must comply with the facilities require- swinging motion; ments in § 381.36(f). (E) The establishment must ensure (ii) Carcass sorting and disposition. (A) that it can sufficiently identify viscera The establishment must conduct car- and parts corresponding with each carcass with associated viscera sorting ac- cass inspected by the online carcass in- tivities, dispose of carcasses and parts spector so that if the carcass inspector exhibiting condemnable conditions, condemns a carcass all corresponding and conduct appropriate trimming and viscera and parts are also condemned. reprocessing activities before carcasses (iv) Inspection for Avian Visceral Leu- are presented to the online carcass in- kosis. (A) Establishments that slaugh- spector. ter young chickens must notify the in- (B) Any carcasses removed from the spector-in-charge prior to the slaugh- line for reprocessing activities or sal- ter of each new flock to allow the in- vage must be returned to the line be- spection of viscera as provided in fore the online carcass inspection sta- § 381.36(f)(3). tion. The establishment must include (B) If there is evidence that a flock in its written HACCP plan, or sanita- may be affected by avian visceral leu- tion SOP, or other prerequisite pro- kosis, the inspector-in-charge is au- gram a process by which parts, other thorized to adjust inspection proce- than parts identified as ‘‘major portions’’ as defined in § 381.170(b)(22), are dures as needed to ensure adequate in- available for inspection offline after re- spection of each carcass and viscera for processing or salvage. that condition. The inspector-in-charge (C) The establishment must develop, implement, and maintain written procedures to ensure that poultry carcasses contaminated with septicemic

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is also authorized to require the estab- found to be not adulterated shall be lishment to adjust its processing oper- passed for human food. ations as needed to accommodate the adjusted inspection procedures. § 381.80 General; biological residues. (Recordkeeping requirements approved by (a) The carcasses or parts of car- the Office of Management and Budget under casses of all poultry inspected at an of- control number 0583–0008) ficial establishment and found at the time of post mortem inspection, or at [47 FR 23435, May 28, 1982, as amended at 49 any subsequent inspection, to be af- FR 42555, Oct. 23, 1984; 50 FR 37513, Sept. 16, 1985; 50 FR 38097, Sept. 20, 1985; 51 FR 3574, fected with any of the diseases or con- Jan. 29, 1986; 53 FR 46861, Nov. 21, 1988; 62 FR ditions named in other sections in this 5143, Feb. 4, 1997; 65 FR 34390, May 30, 2000; 66 subpart, shall be disposed of in accord- FR 22906, May 7, 2001; 79 FR 49635, Aug. 21, ance with the section pertaining to the 2014] disease or condition. Owing to the fact that it is impracticable to formulate § 381.77 Carcasses held for further ex- rules for each specific disease or condi- amination. tions and to designate at just what Each carcass, including all parts stage a disease process results in an thereof, in which there is any lesion of adulterated article, the decision as to disease, or other condition which the disposal of all carcasses, organs or might render such carcass or any part other parts not specifically covered by thereof adulterated and with respect to the regulations, or by instructions of which a final decision cannot be made the Administrator issued pursuant on first examination by the inspector, thereto, shall be left to the inspector in shall be held for further examination. charge, and if the inspector in charge is The identity of each such carcass, in- in doubt concerning the disposition to cluding all parts thereof, shall be main- be made, specimens from such car- tained until a final examination has casses shall be forwarded to the Inspec- been completed. tion Service laboratory for diagnosis. (b) All carcasses, organs, or other § 381.78 Condemnation of carcasses parts of carcasses of poultry shall be and parts: separation of poultry condemned if it is determined on the suspected of containing biological basis of a sound statistical sample that residues. they are adulterated because of the (a) At the time of any inspection presence of any biological residues. under this subpart each carcass, or any part thereof, which is found to be adul- § 381.81 Tuberculosis. terated shall be condemned, except Carcasses of poultry affected with tu- that any such articles which may be berculosis shall be condemned. made not adulterated by reprocessing, need not be so condemned if so reproc- § 381.82 Diseases of the leukosis com- essed under the supervision of an in- plex. spector and thereafter found to be not Carcasses of poultry affected with adulterated. any one or more of the several forms of (b) When a lot of poultry suspected of the avian leukosis complex shall be containing biological residues is in- condemned. spected in an official establishment, all carcasses and any parts of carcasses in § 381.83 Septicemia or toxemia. such lot which are condemned shall be Carcasses of poultry showing evi- kept separate from all other con- dence of any septicemic or toxemic dis- demned carcasses or parts. ease, or showing evidence of an abnor- [37 FR 9706, May 16, 1972, as amended at 48 mal physiologic state, shall be con- FR 22899, May 23, 1983; 48 FR 23807, May 27, demned. 1983] § 381.84 Airsacculitis. § 381.79 Passing of carcasses and Carcasses of poultry with evidence of parts. extensive involvement of the air sacs Each carcass and all organs and with airsacculitis or those showing other parts of carcasses which are airsacculitis along with systemic

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changes shall be condemned. Less af- gases, scald vat water in the air sac fected carcasses may be passed for food system, or other substances which after complete removal and condemna- render the carcasses adulterated shall tion of all affected tissues including be condemned. Any organ or other part the exudate. of a carcass which has been acciden- [40 FR 14297, Mar. 31, 1975] tally multilated in the course of processing shall be condemned, and if the § 381.85 Special diseases. whole carcass is affected, the whole Carcasses of poultry showing evi- carcass shall be condemned. dence of any disease which is charac- (b) Any carcass of poultry acciden- terized by the presence, in the meat or tally contaminated during slaughter other edible parts of the carcass, or or- with digestive tract contents need not ganisms or toxins dangerous to the be condemned if promptly reprocessed consumer, shall be condemned. under the supervision of an inspector and thereafter found not to be adulter- § 381.86 Inflammatory processes. ated. Contaminated surfaces that are Any organ or other part of a carcass cut must be removed only by trim- which is affected by an inflammatory ming. Contaminated inner surfaces process shall be condemned and, if that are not cut may be cleaned by there is evidence of general systemic trimming alone or may be re-processed disturbance, the whole carcass shall be as provided in subparagraph (b)(1) or (2) condemned. of this section. (1) Online reprocessing. Poultry car- § 381.87 Tumors. casses accidentally contaminated with Any organ or other part of a carcass digestive tract contents may be which is affected by a tumor shall be cleaned by applying an online reproc- condemned and when there is evidence essing antimicrobial intervention to of metastasis or that the general condi- all carcasses after evisceration and be- tion of the bird has been affected by fore the carcasses enter the chiller if the size, position, or nature of the the parameters for use of the anti- tumor, the whole carcass shall be con- microbial intervention system have demned. been approved by the Administrator. Establishments must incorporate pro- § 381.88 Parasites. cedures for the use of any online re- Organs or other parts of carcasses processing antimicrobial intervention which are found to be infested with system into their HACCP plans, or parasites, or which show lesions of sanitation SOPs, or other prerequisite such infestation shall be condemned programs. and, if the whole carcass is affected, (2) Offline reprocessing. Contaminated the whole carcass shall be condemned. inner surfaces that are not cut may be cleaned at an approved reprocessing § 381.89 Bruises. station away from the main processing Any part of a carcass which is badly line by any method that will remove bruised shall be condemned and, if the the contamination, such as vacuuming, whole carcass is affected as a result of washing, and trimming, singly or in the bruise, the whole carcass shall be combination. All visible specks of con- condemned. Parts of a carcass which tamination must be removed, and if show only slight reddening from a the inner surfaces are reprocessed bruise may be passed for food. other than solely by trimming, all surfaces of the carcass must be treated § 381.90 Cadavers. with chlorinated water containing 20 Carcasses of poultry showing evi- ppm to 50 ppm available chlorine or an- dence of having died from causes other other approved antimicrobial sub- than slaughter shall be condemned. stance in accordance with the parameters approved by the Administrator. § 381.91 Contamination. Establishments must incorporate pro- (a) Carcasses of poultry contami- cedures for the use of any offline re- nated by volatile oils, paints, poisons, processing into their HACCP plans, or

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sanitation SOPs, or other prerequisite specimen collection procedures which programs. shall identify employees designated to collect samples, and shall address loca- [37 FR 9706, May 16, 1972, as amended at 43 FR 12847, Mar. 28, 1978; 79 FR 49636, Aug. 21, tion(s) of sampling, how sampling ran- 2014] domness is achieved, and handling of the sample to ensure sample integrity. § 381.92 Overscald. The written procedure shall be made Carcasses of poultry which have been available to FSIS upon request. overscalded, resulting in a cooked ap- (ii) Sample collection. The establish- pearance of the flesh, shall be con- ment must collect samples from whole demned. ratites at the end of the chilling process. Samples from ratites may be col- § 381.93 Decomposition. lected by sponging the carcass on the Carcasses of poultry deleteriously af- back and thigh or samples can be col- fected by post mortem changes shall be lected by rinsing the whole carcass in disposed of as follows: an amount of buffer appropriate for (a) Carcasses which have reached a that type of bird. state of putrefaction or stinking fer- (iii) Sampling frequency. Establish- mentation shall be condemned. ments that slaughter ratites, except (b) Any part of a carcass which is very low volume ratite establishments green struck shall be condemned and, if as defined in paragraph (a)(2)(v) of this the carcass is so extensively affected section, must take samples at a fre- that removal of affected parts is im- quency proportional to the establish- practicable, the whole carcass shall be ment’s volume of production at the fol- condemned. lowing rate: 1 sample per 3,000 car- (c) Carcasses affected by types of post casses, but at a minimum one sample mortem change which are superficial each week of operation. in nature may be passed for human (iv) Sampling frequency alternatives. food after removal and condemnation An establishment operating under a of the affected parts. validated HACCP plan in accordance with § 417.2(b) of this chapter may sub- § 381.94 Contamination with micro- stitute an alternative frequency for the organisms; process control frequency of sampling required under verification criteria and testing; paragraph (a)(2)(iii) of this section if, pathogen reduction standards for (A) The alternative is an integral establishments that slaughter part of the establishment’s verification ratites. procedures for its HACCP plan and, (a) Criteria for verifying process control; (B) FSIS does not determine, and no- E. coli testing. (1) Each official estab- tify the establishment in writing, that lishment that slaughters ratites shall the alternative frequency is inadequate test for Escherichia coli Biotype I (E. to verify the effectiveness of the estab- coli). Establishments that slaughter lishment’s processing controls. ratites and livestock, shall test the (v) Sampling in very low volume ratite type of ratites or livestock slaughtered establishments. (A) Very low volume in the greatest number. The establish- ratite establishments annually slaugh- ment shall: ter no more than 6,000 ratites. Very low (i) Collect samples in accordance volume ratite establishments that with the sampling techniques, method- slaughter ratites in the largest number ology, and frequency requirements in must collect at least one sample during paragraph (a)(2) of this section; each week of operation after June 1 of (ii) Obtain analytic results in accord- each year, and continue sampling at a ance with paragraph (a)(3) of this sec- minimum of once each week the estab- tion; and lishment operates until June of the fol- (iii) Maintain records of such ana- lowing year or until 13 samples have lytic results in accordance with para- been collected, whichever comes first. graph (a)(4) of this section. (B) Upon the establishment’s meeting (2) Sampling requirements. (i) Written the requirements of paragraph procedures. Each establishment that (a)(2)(v)(A) of this section, weekly sam- slaughters ratites shall prepare written pling and testing is optional, unless

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changes are made in establishment fa- (b) [Reserved] cilities, equipment, personnel or proce- [61 FR 38866, July 25, 1996, as amended at 62 dures that may affect the adequacy of FR 26218, May 13, 1997; 62 FR 61009, Nov. 14, existing process control measures, as 1997; 64 FR 66553, Nov. 29, 1999; 67 FR 13258, determined by the establishment or by Mar. 22, 2002; 79 FR 49636, Aug. 21, 2014] FSIS. FSIS determinations that changes have been made requiring re- Subpart L—Handling and Disposal sumption of weekly testing shall be of Condemned or Other Ined- provided to the establishment in writ- ible Products at Official Estab- ing. (3) Analysis of samples. Laboratories lishments may use any quantitative method for § 381.95 Disposal of condemned poul- analysis of E. coli that is approved as try products. an AOAC Official Method of the AOAC All condemned carcasses, or con- International (formerly the Associa- demned parts of carcasses, or other tion of Official Analytical Chemists) or condemned poultry products, except approved and published by a scientific those condemned for biological resi- body and based on the results of a col- dues shall be disposed of by one of the laborative trial conducted in accord- following methods, under the super- ance with an internationally recog- vision of an inspector of the Inspection nized protocol on collaborative trials Service. (Facilities and materials for and compared against the three tube carrying out the requirements in this Most Probable Number (MPN) method section shall be furnished by the offi- and agreeing with the 95 percent upper cial establishment.) and lower confidence limit of the ap- (a) Steam treatment (which shall be propriate MPN index. accomplished by processing the con- (4) Recording of test results. The estab- demned product in a pressure tank lishment shall maintain accurate under at least 40 pounds of steam pres- records of all test results, in terms of sure) or thorough cooking in a kettle colony forming units (CFU)/ml of rinse or vat, for a sufficient time to effec- fluid. Results shall be recorded onto a tively destroy the product for human process control chart or table showing food purposes and preclude dissemina- at least the most recent 13 test results. tion of disease through consumption by Records shall be retained at the estab- animals. (Tanks and equipment used lishment for a period of 12 months and for this purpose or for rendering or pre- shall be made available to FSIS upon paring inedible products shall be in request. rooms or compartments separate from (5) Establishments shall evaluate E. those used for the preparation of edible coli test results using statistical proc- products. There shall be no direct con- ess control techniques. nection by means of pipes, or other- (6) Failure to meet criteria. Test results wise, between tanks containing ined- that do not meet the criteria described ible products and those containing edi- in paragraph (a)(5) of this section are ble products.) an indication that the establishment (b) Incineration or complete destruc- may not be maintaining process con- tion by burning. trols sufficient to prevent fecal con- (c) Chemical denaturing, which shall tamination. FSIS shall take further ac- be accomplished by the liberal application as appropriate to ensure that all tion to all carcasses and parts thereof, applicable provisions of the law are of: being met. (1) Crude carbolic acid, (7) Failure to test and record. Inspec- (2) Kerosene, fuel oil, or used crank- tion will be suspended in accordance case oil, or with rules of practice that will be (3) Any phenolic disinfectant con- adopted for such proceeding, upon a forming to commercial standards CS finding by FSIS that one or more pro- 70–41 or CS 71–41 which shall be used in visions of paragraphs (a) (1) through (4) at least 2 percent emulsion or solution. of this section have not been complied (d) Any other substance or method with and written notice of same has that the Administrator approves in been provided to the establishment. specific cases, which will denature the

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poultry product to the extent nec- curely affixed to such containers of essary to accomplish the purposes of such products and may be printed or this section. stenciled thereon, but shall not be ap- (e) Carcasses and parts of carcasses plied by rubber stamping. When applied condemned for biological residue shall by a stencil, the legend shall not be be disposed of in accordance with para- less than 4 inches in diameter. An offi- graph (b) of this section or by burying cial brand must be applied to inspected under the supervision of an inspector. and passed carcasses and parts of ratites that are shipped unpacked. Subpart M—Official Marks, De- vices, and Certificates; Export Certificates; Certification Pro- cedures § 381.96 Wording and form of the official inspection legend. Except as otherwise provided in this subpart, the official inspection legend required to be used with respect to inspected and passed poultry products shall include wording as follows: ‘‘In- spected for wholesomeness by U.S. De- partment of Agriculture.’’ This wording shall be contained within a circle. The form and arrangement of such wording shall be exactly as indicated in the example in Figure 1, except that the appropriate official establishment number shall be shown, and if the establishment number appears elsewhere on the labeling material in the manner [66 FR 22906, May 7, 2001] prescribed in § 381.123(b), it may be omitted from the inspection mark. The § 381.97 [Reserved] administrator may approve the use of abbreviations of such inspection mark; § 381.98 Official seal. and such approved abbreviations shall The official mark for use in sealing have the same force and effect as the means of conveyance used in trans- inspection mark. The official inspec- porting poultry products under any re- tion legend, or the approved abbrevia- quirement in this part shall be the in- tion thereof, shall be printed on con- scription and a serial number as shown sumer packages and other immediate below, and any seals approved by the containers of inspected and passed Administrator for applying such mark poultry products, or on labels to be se- shall be an official device.

§ 381.99 Official retention and rejec- (a) A paper tag (a portion of Form tion tags. MP–35) bearing the legend ‘‘U.S. Re- The official marks for use in post- tained’’ for use on poultry or poultry mortem inspection and identification products under this section. of adulterated products, insanitary (b) A paper tag (another portion of equipment and facilities are: Form C&MS 510) bearing the legend ‘‘U.S. Rejected’’ for use on equipment,

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utensils, rooms and compartments § 381.104 Official export certificates, under this section. marks and devices. [64 FR 56417, Oct. 20, 1999] The form of certificate described in § 381.106 is an official export certificate, § 381.100 Official detention tag. and the mark shown below is the offi- The detention tag prescribed in cial mark used on outside containers to § 381.211 is an official device. identify inspected and passed poultry products for export. Devices used by § 381.101 Official U.S. Condemned the Department to apply such a mark mark. are official devices. The term ‘‘U.S. Condemned’’ as shown below is an official mark and the devices used by the Department for applying such mark are official devices.

§ 381.102 [Reserved] [47 FR 29823, July 9, 1982]

§ 381.103 Official poultry condemna- § 381.105 Export certification; marking tion certificates; issuance and form. of containers. Upon request by the operator of the (a) Upon request or application by establishment, the inspector in charge any person intending to export any shall issue a poultry condemnation cer- poultry product, any inspector is au- tificate (Form MP–514–1), showing the thorized to issue an official export cer- total number of poultry in the lot and tificate as prescribed in § 381.107 with the numbers condemned and the rea- respect to the shipment to any foreign sons for such condemnations. country of any inspected and passed The official poultry condemnation poultry product, after adequate inspec- certificate authorized by this subpart tion of the product has been made by is a paper certificate (Form MP–514–1), the inspector to determine its identity for signature by an inspector, bearing as inspected and passed and eligible for the legend export: Provided, that the product is of- U.S. DEPARTMENT OF AGRICULTURE ANI- fered for inspection at an official establishment. Each shipping container cov- MAL AND PLANT HEALTH INSPECTION ered by the export certificate, except SERVICE ship stores, small quantities exclu- POULTRY CONDEMNATION CERTIFICATE sively for the personal use of the consignee and not for sale or distribution, and the seal of the United States De- and shipments by and for the U.S. partment of Agriculture, with a certifi- Armed Forces, shall be marked with an cation that the poultry enumerated on official export stamp as shown in the form were inspected and con- § 381.104 bearing the number of the ex- demned for the listed causes in compli- port certificate. Official export certifi- ance with the regulations of the De- cates will be issued only upon condi- partment. A statement to the effect tion that the products covered thereby that certain figures on the certificate shall be subject to reinspection at any were derived from information supplied place and at any time prior to expor- by plant management, and a signature tation to determine the identity of the line for an authorized plant official is products and their eligibility for cer- also shown. tification, and such certificates shall

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become invalid if such reinspection is ‘‘MPA 002805’’, and shows the respec- refused or discloses that the products tive names of the exporter and con- are not eligible for certification. If re- signee, the destination, the shipping inspection discloses that any poultry marks, the names of such products, the products covered by an export certifi- total net weight thereof, and such cate are not eligible for such certifi- other information as the Adminis- cation, a superseding certificate set- trator may prescribe or approve in spe- ting forth such findings shall be issued cific cases. and copies shall be furnished to interested persons. [47 FR 29823, July 9, 1982] (b) The original and a duplicate of each official export certificate shall be § 381.107 Special procedures as to certification of poultry products for ex- delivered to the person who requested port to certain countries. such certificate or his agent. Such person may duplicate such numbers of When export certificates are required exact copies of the original as he re- by any foreign country for poultry quires in connection with the expor- products exported to such country, the tation of the poultry products. Addi- Administrator shall in specific cases tional official file copies of the export prescribe or approve the form of export certificates shall be prepared and dis- certificate to be used and the methods tributed by the inspector in accordance and procedures he deems appropriate with the instructions of the Adminis- with respect to the processing of such trator. products, in order to comply with re- (c) Only one certificate shall be quirements specified by the foreign issued for each consignment, except in country regarding the export products. case of error in the certificate or loss Inspectors shall satisfy themselves of the certificate originally issued. A that all such requirements are met be- request for a new certificate, except in fore issuing such an export certificate. the case of a lost certificate, shall be It shall be the responsibility of the ex- accompanied by the original and all porter to provide any unofficial docu- copies of the first certificate. The new mentation needed to meet the foreign certificate shall carry the following requirements, before the export certifi- statement: ‘‘This certificate supersedes cate will be issued. Such certificates certificate No. lll Dated lllll. may also cover articles exempted from The outside container of the poultry definition as a poultry product under product covered by this certificate is § 381.15 if they have been inspected and stamped with United States Depart- are certified under the regulations in ment of Agriculture Certificate No. part 362 of this chapter. .’’ lll [37 FR 9706, May 16, 1972, as amended at 39 [37 FR 9706, May 16, 1972, as amended at 50 FR 4569, Feb. 5, 1974; 41 FR 23702, June 11, FR 25204, June 18, 1985] 1976]

§ 381.106 Form of official export cer- § 381.108 Official poultry inspection tificate. certificates; issuance and disposi- The official export certificate au- tion. thorized by this subpart is a paper cer- (a) Upon the request of an interested tificate form for signature by an in- party, any veterinary inspector is au- spector, bearing a letterhead and the thorized to issue an official poultry in- seal of the U.S. Department of Agri- spection certificate with respect to any culture, with a certification that the lot of slaughtered poultry inspected by slaughtered poultry and other poultry him. At any official establishment products described on the form came each such certificate shall be signed by from birds that were officially given an the inspector who made the inspection ante-mortem and post-mortem inspec- covered by the certificate, and if more tion and passed in accordance with the than one inspector participated in the regulations of the Department and that inspection of the lot of poultry, each such products are wholesome and fit such inspector shall sign the certificate for human consumption. The certifi- with respect to such lot. If the inspec- cate also bears a serial number, such as tion of a lot covered by a certificate

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was made by a food inspector, such cer- permitted on any official certificate or tificate shall also be signed by the in- any copy thereof. All certificates ren- spector in charge when such inspection dered useless through clerical error or was made. Any inspector is authorized otherwise and all certificates canceled to issue a poultry inspection certificate for whatever cause shall be voided and with respect to any other poultry prod- initialed, and one copy shall be re- uct inspected by him. tained in the inspector’s file; and the (b) The original and one copy of each original and all other copies shall be poultry inspection certificate shall be forwarded to the appropriate program issued to the applicant who requested supervisor. such certificate, and one copy shall be retained by the inspector for filing. § 381.111 Data to be entered in proper The inspector who issues any inspec- spaces. tion certificate is authorized to furnish All certificates shall be so executed an additional copy of such certificate that the data entered thereon will ap- upon the request of an interested pear in the proper spaces on each copy party. The person who sold the live of the certificate. poultry involved to the official establishment is an interested party for pur- § 381.112 Official mark for maintaining poses of this section. the identity and integrity of samples. [37 FR 9706, May 16, 1972, as amended at 39 FR 36000, Oct. 7, 1974] The official mark for use in sealing containers of samples submitted under § 381.109 Form of official poultry in- any requirements in this part and sec- spection certificate. tion 11(b) of the Poultry Products In- (a) The official poultry inspection spection Act shall bear the designation certificate authorized by this subpart ‘‘Sample Seal’’ accompanied by the of- is a paper certificate (Form MP–505) for ficial USDA logo as shown below. Any signature by an inspector, bearing the seal approved by the Administrator for legend applying such mark shall be deemed an official device for purposes of the Act. U.S. DEPARTMENT OF AGRICULTURE ANI- Such device shall be supplied to inspec- MAL AND PLANT HEALTH INSPECTION tors, compliance officers, and other SERVICE MEAT AND POULTRY INSPEC- designated Agency officials by the TION PROGRAM United States Department of Agri- culture. POULTRY INSPECTION CERTIFICATE and the seal of the U.S. Department of Agriculture, with a certification that the poultry described therein had been inspected in compliance with the Regu- lations of the Secretary of Agriculture Governing the Inspection of Poultry and Poultry Products. (b) The certificate also bears a serial number such as ‘‘B 3208’’ and shows the respective name and address of the applicant, the shipper or seller and the [52 FR 41958, Nov. 2, 1987] receiver or buyer and the net weight in pounds of amount passed, amount re- Subpart N—Labeling and jected or condemned, type of poultry, Containers lot number and class, and such other information as the Administrator may § 381.115 Containers of inspected and prescribe or approve in specific cases. passed poultry products required to be labeled. § 381.110 Erasures or alterations made Except as may be authorized in spe- on certificates. cific cases by the Administrator with Erasures or alterations not initialed respect to shipment of poultry prod- by the issuing inspector shall not be ucts between official establishments,

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each shipping container and each im- height of which is as high as the con- mediate container of any inspected and tainer: Provided, however, That there is, passed poultry product shall at the immediately to the right or left of such time it leaves the official establish- principal display panel, a panel which ment bear a label which contains infor- has a width not greater than 20 percent mation, and has been approved, in ac- of the circumference and a height as cordance with this subpart. high as the container, and which is reserved for information prescribed in § 381.116 Wording on labels of imme- §§ 381.118, 381.122, and 381.123. Such diate containers. panel shall be known as the ‘‘20 percent (a) Each label for use on immediate panel’’ and such information may be containers for inspected and passed shown on that panel in lieu of showing poultry products shall bear on the prin- it on the principal display panel as pro- cipal display panel (except as otherwise vided in this § 381.116. permitted in the regulations), the (3) In the case of a container of any items of information required by this other shape, 40 percent of the total sur- subpart. Such items of information face of the container. shall be in distinctly legible form. Ex- cept as provided in § 381.128, all words, In determining the area of the prin- statements and other information re- cipal display panel, exclude tops, bot- quired by or under authority of the Act toms, flanges at tops and bottoms of to appear on the label or labeling shall cans, and shoulders and necks of bot- appear thereon in the English lan- tles or jars. guage: Provided, however, That in the (c) (1) The information panel is that case of products distributed solely in part of a label that is the first surface Puerto Rico, Spanish may be sub- to the right of the principal display stituted for English for all printed panel as observed by an individual fac- matter except the USDA inspection ing the principal display panel, with legend. the following exceptions: (b) The principal display panel shall (i) If the first surface to the right of be the part of a label that is most like- the principal display panel is too small ly to be displayed, presented, shown, or to accommodate the required informa- examined under customary conditions tion or is otherwise unusable label of display for sale. The principal dis- space, e.g., folded flaps, tear strips, play panel shall be large enough to ac- opening flaps, heat-sealed flaps, the commodate all the mandatory label in- next panel to the right of this part of formation required to be placed there- the label may be used. on by the regulations with clarity and (ii) If the package has one or more al- conspicuousness and without being ob- ternate principal display panels, the in- scured by design or vignettes, or formation panel is to the right of any crowding. Where packages bear alter- principal display panel. nate principal display panels, information required to be placed on the prin- (iii) If the top of the container is the cipal display panel shall be duplicated principal display panel and the pack- on each principal display panel. The age has no alternate principal display area that is to bear the principal dis- panel, the information panel is any play panel shall be: panel adjacent to the principal display (1) In the case of a rectangular pack- panel. age, one entire side, the area of which (2) (i) Except as otherwise permitted is the product of the height times the in this part, all information required to width of that side. appear on the principal display panel (2) In the case of a cylindrical or or permitted to appear on the informa- nearly cylindrical container: tion panel shall appear on the same (i) An area on the side of the con- panel unless there is insufficient space. tainer that is 40 percent of the product In determining the sufficiency of the of the height of the container times the available space, except as otherwise circumference, or prescribed in this part, any vignettes, (ii) A panel, the width of which is designs, and any other nonmandatory one-third of the circumference and the information shall not be considered. If

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there is insufficient space for all re- appropriate names for cut-up parts are quired information to appear on a sin- set forth in § 381.170(b). When naming gle panel, it may be divided between parts cut from young poultry, the iden- the principal display panel and the in- tity of both the kind of poultry and the formation panel, provided that the in- name of the part shall be included in formation required by any given provi- the product name. The product name sion of this part, such as the ingredi- for parts or portions cut from mature ents statement, is not divided and ap- poultry shall include, along with the pears on the same panel. part or portion name, the class name (ii) All information appearing on the or the qualifying term ‘‘mature.’’ The information panel pursuant to this sec- name of the product for cooked or heat tion shall appear in one place without processed poultry products shall in- intervening material, such as designs clude the kind name of the poultry or vignettes. from which the product was prepared [37 FR 9706, May 16, 1972, as amended at 40 but need not include the class name or FR 11347, Mar. 11, 1975; 59 FR 40214, Aug. 8, the qualifying term ‘‘mature.’’ 1994] (c) Poultry products containing light and dark chicken or turkey meat in § 381.117 Name of product and other quantities other than the natural pro- labeling. portions, as indicated in Table 1 in this (a) The label shall show the name of paragraph, must have a qualifying the product, which, in the case of a statement in conjunction with the poultry product which purports to be name of the product indicating, as or is represented as a product for which shown in Table 1, the types of meat ac- a definition and standard of identity or tually used, except that when the prod- composition is prescribed in subpart P, uct contains less than 10 percent shall be the name of the food specified cooked deboned poultry meat or is in the standard, and in the case of any processed in such a manner that the other poultry product shall be the com- character of the light and dark meat is mon or usual name of the food, if any not distinguishable, the qualifying there be, and if there is none, a truth- statement will not be required, unless ful descriptive designation. the product bears a label referring to (b) The name of the product required the light or dark meat content. In the to be shown on labels for fresh or fro- latter case, the qualifying statement is zen raw whole carcasses of poultry required if the light and dark meat are shall be in either of the following not present in natural proportions. The forms: The name of the kind (such as qualifying statement must be in type chicken, turkey, or duck) preceded by at least one-half the size and of equal the qualifying term ‘‘young’’ or ‘‘ma- boldness as the name of the product; ture’’ or ‘‘old’’, whichever is appro- e.g., Boned Turkey (Dark Meat). priate; or the appropriate class name as described in § 381.170(a). The name of TABLE 1 the kind may be used in addition to the Percent light Percent class name, but the name of the kind Label terminology meat dark meat alone without the qualifying age or Natural proportions ...... 50–65 50–35 class term is not acceptable as the Light or white meat ...... 100 0 name of the product, except that the Dark meat ...... 0 100 name ‘‘chicken’’ may be used without Light and dark meat ...... 51–65 49–35 Dark and light meat ...... 35–49 65–51 such qualification with respect to a Mostly white meat ...... 66 or more 34 or less ready-to-cook pack of fresh or frozen Mostly dark meat ...... 34 or less 66 or more cut-up young chickens, or a half of a young chicken, and the name (d) Boneless poultry products shall be ‘‘duckling’’ may be used without such labeled in a manner that accurately de- qualification with respect to a ready- scribes their actual form and composi- to-cook pack of fresh or frozen young tion. The product name shall specify ducks. The class name may be appro- the form of the product (e.g., priately modified by changing the word emulsified, finely chopped, etc.), and form, such as using the term ‘‘roasting the kind name of the poultry, and if chicken’’, rather than ‘‘roaster.’’ The the product does not consist of natural

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proportions of skin and fat, as they cipal display panel or in the ingredient occur in the whole carcass, shall also statement. include terminology that describes the [37 FR 9706, May 16, 1972, as amended at 60 actual composition. If the product is FR 55983, Nov. 3, 1995; 66 FR 40845, Aug. 6, cooked, it shall be so labeled. For the 2001] purpose of this paragraph, natural pro- EFFECTIVE DATE NOTE: At 79 FR 79061, Dec. portions of skin, as found on a whole 31, 2014, § 381.117 was amended by adding chicken or turkey carcass, will be con- paragraph (h), effective Jan. 1, 2016. For the sidered to be as follows: convenience of the user, the added text is set forth as follows: Percent § 381.117 Name of product and other label- Raw Cooked ing.

Chicken ...... 20 25 Turkey ...... 15 20 * * * * * (h) The product name for a raw poultry Boneless poultry product shall not product that contains added solution and have a bone solids content of more does not meet a standard of identity in this than 1 percent, calculated on a weight part must contain a descriptive designation that includes: basis. (1) The percentage of added solution (total (e) On the label of any ‘‘Mechanically weight of the solution ingredients divided by Separated (Kind of Poultry) ‘‘ described the weight of the raw poultry without solu- in § 381.173, the name of such product tion or any other added ingredients multi- shall be followed immediately by the plied by 100). The percentage of added solution must appear as a number (such as, 15, 20, phrase: ‘‘with excess skin’’ unless such 30) and the percent symbol (%). The percent- product is made from poultry product age of added solution may be declared by the that does not include skin in excess of words ‘‘containing’’ or ‘‘contains’’ (such as, the natural proportion of skin present ‘‘contains 15% added solution of water and on the whole carcass, as specified in salt,’’ or ‘‘containing 15% added solution of paragraph (d) of this section. Appro- water and teriyaki sauce’’). (2) The common or usual name of all indi- priate terminology on the label shall vidual ingredients or multi-ingredient com- indicate if heat treatment has been ponents in the solution listed in descending used in the preparation of the product. order of predominance by weight. The labeling information described in (3) When the descriptive designation in- this paragraph shall be identified on cludes all ingredients in the solution, a sepa- the label before the product leaves the rate ingredients statement is not required on the label. When the descriptive designation establishment at which it is manufac- includes multi-ingredient components and tured. the ingredients of the component are not de- (f) The labels of sausages encased in clared in the product name, all ingredients natural casings made from meat or in the product must be declared in a separate poultry viscera shall identify the type ingredients statement on the label as re- of meat or poultry from which the cas- quired in § 381.118. (4) The product name and the descriptive ings were derived, if the casings are designation must be printed in a single easy- from a different type of meat or poul- to-read type style and color and must appear try than the encased meat or poultry. on a single-color contrasting background. The identity of the casing, if required, The print may appear in upper and lower may be placed on the principal display case letters, with the lower case letters not 1 panel or in the ingredient statement. smaller than one-third ( ⁄3) the size of the largest letter. Establishments producing, manufac- (5) The word ‘‘enhanced’’ cannot be used in turing, or using natural sausage cas- the product name. ings are to maintain records documenting the meat or poultry source in § 381.118 Ingredients statement. accordance with subpart Q of this part. (a)(1) The label shall show a state- (g) The labels of sausages encased in ment of the ingredients in the poultry regenerated collagen casings shall dis- product if the product is fabricated close this fact on the product label. from two or more ingredients. Such in- The fact that the sausage is encased in gredients shall be listed by their com- collagen may be placed on the prin- mon or usual names in the order of

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their descending proportions, except as (1) The term ‘‘spice’’ means any aro- prescribed in paragraph (a)(2) of this matic vegetable substance in the section. whole, broken, or ground form, with (2)(i) Product ingredients which are the exceptions of onions, garlic and present in individual amounts of 2 per- celery, whose primary function in food cent or less by weight may be listed in is seasoning rather than nutritional the ingredients statement in other and from which no portion of any vola- than descending order of predomi- tile oil or other flavoring principle has nance: Provided, That such ingredients been removed. Spices include the spices are listed by their common or usual listed in 21 CFR 182.10, and 184. names at the end of the ingredients (2) The term ‘‘natural flavor,’’ ‘‘nat- statement and preceded by a quanti- ural flavoring,’’ ‘‘flavor’’ or ‘‘fla- fying statement, such as ‘‘Contains voring’’ means the essential oil, oleo- lllll percent or less of lllll resin, essence or extractive, protein hy- ,’’ or ‘‘Less than lllll percent of drolysate, distillate, or any product of lllll .’’ The percentage of the in- roasting, heating or enzymolysis, gredient(s) shall be filled in with a which contains the flavoring constitu- threshold level of 2 percent, 1.5 percent, ents derived from a spice, fruit or fruit 1.0 percent, or 0.5 percent, as appro- juice, vegetable or vegetable juice, edi- priate. No ingredient to which the ble yeast, herb, bark, bud, root, leaf or quantifying statement applies may be any other edible portions of a plant, present in an amount greater than the meat, seafood, poultry, eggs, dairy stated threshold. Such a quantifying products, or fermentation products statement may also be utilized when thereof, whose primary function in an ingredients statement contains a food is flavoring rather than nutri- listing of ingredients by individual tional. Natural flavors include the nat- components. Each component listing ural essence or extractives obtained may utilize the required quantifying from plants listed in 21 CFR 182.10, statement at the end of each compo- 182.20, 182.40, 182.50 and 184, and the nent ingredients listing. substances listed in 21 CFR 172.510. The (ii) Such ingredients may be adjusted term natural flavor, natural flavoring, in the product formulation without a flavor or flavoring may also be used to change being made in the ingredients designate spices, powdered onion, pow- statement on the labeling, provided dered garlic, and powdered celery. that the adjusted amount complies with subpart P of this part and (i) Natural flavor, natural flavoring, § 424.21(c) of subchapter E, and does not flavor or flavoring as described in para- exceed the amount shown in the quan- graph (c)(1) and (2) of this section, tifying statement. Any such adjust- which are also colors shall be des- ments to the formulation shall be pro- ignated as ‘‘natural flavor and color- vided to the inspector-in-charge. ing,’’ ‘‘natural flavoring and coloring,’’ (b) For the purpose of this paragraph, ‘‘flavor and coloring’’ or ‘‘flavoring and the term ‘‘chicken meat,’’ unless modi- coloring’’ unless designated by their fied by an appropriate adjective, is con- common or usual name. strued to mean deboned white and dark (ii) Any ingredient not designated in meat; whereas the term ‘‘chicken’’ may paragraphs (c) (1) and (2) of this section include other edible parts such as skin whose function is flavoring, either in and fat not in excess of their natural whole or in part, must be designated by proportions, in addition to the chicken its common or usual name. Those in- meat. If the term ‘‘chicken meat’’ is gredients which are of livestock or listed and the product also contains poultry origin must be designated by skin, giblets, or fat, it is necessary to names that include the species and list each such ingredient. Similar prin- livestock and poultry tissues from ciples shall be followed in listing ingre- which the ingredients are derived. dients of poultry products processed (d) On containers of frozen dinners, from other kinds of poultry. entrees, and pizzas, and similarly pack- (c) The terms spice, natural flavor, aged products in cartons, the ingre- natural flavoring, flavor or flavoring dient statement may be placed on the may be used in the following manner: front riser panel: Provided, That the

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words ‘‘see ingredients,’’ followed im- or contains any artificial coloring shall mediately by an arrow pointing to the bear a statement stating that fact on front riser panel, are placed on the the immediate container or, if there is principal display panel immediately none, on the product. above the location of such statement, without intervening printing or de- § 381.120 Antioxidants; chemical pre- signs. servatives; and other additives. (e) The ingredients statement may be When an antioxidant is added to a placed on the information panel, ex- poultry product, there shall appear on cept as otherwise permitted in this the label in prominent letters and con- subchapter. tiguous to the name of the product, a (f) Establishments may interchange statement showing the name of the the identity of two kinds of poultry antioxidant and the purpose for which (e.g., chicken and turkey, chicken it is added, such as ‘‘BHA added to help meat and turkey meat) used in a prod- protect the flavor.’’ Immediate con- uct formulation without changing the tainers of poultry products packed in, product’s ingredient statement or prod- bearing, or containing any chemical uct name under the following condi- preservative shall bear a label stating tions: that fact and naming the additive and (1)(i) The two kinds of poultry used the purpose of its use. Immediate con- must comprise at least 70 percent by tainers of poultry products packed in, weight of the poultry and the poultry bearing or containing any other chem- ingredients [e.g. giblets, skin or fat in ical additive shall bear a label naming excess of natural proportions, or me- the additive and the purpose of its use chanically separated (kind)] used; and, when required by the Administrator in (ii) Neither of the two kinds of poul- specific cases. When approved try used can be less than 30 percent by proteolytic enzymes as permitted in a weight of the total poultry and poultry regulation permitting that use in this ingredients used; subchapter or 9 CFR Chapter III, Sub- (2) The word ‘‘and’’ in lieu of a chapter E, or in 21 CFR Chapter I, Sub- comma must be shown between the chapter A or Subchapter B of this sub- declaration of the two kinds of poultry chapter are used in mature poultry in the ingredients statement and in the muscle tissue, there shall appear on product name. the label, in a prominent manner, contiguous to the product name, the state- [37 FR 9706, May 16, 1972, as amended at 55 ment ‘‘Tenderized with [approved en- FR 7294, Mar. 1, 1990; 55 FR 26422, June 28, zyme],’’ to indicate the use of such en- 1990; 58 FR 38049, July 15, 1993; 59 FR 40215, Aug. 8, 1994; 63 FR 11360, Mar. 9, 1998; 76 FR zymes. Any other approved substance 82078, Dec. 30, 2011] which may be used in the solution shall also be included in the statement. § 381.119 Declaration of artificial fla- When approved inorganic chlorides as voring or coloring. permitted in a regulation permitting (a) When an artificial smoke fla- that use in this subchapter or 9 CFR voring or a smoke flavoring is added as Chapter III, Subchapter E, or in 21 CFR an ingredient in the formula of any Chapter I, Subchapter A or Subchapter poultry product, there shall appear on B of this subchapter are used in mature the label, in prominent letters and con- poultry muscle tissue, there shall ap- tiguous to the name of the product, a pear on the label, in a prominent man- statement such as ‘‘Artificial Smoke ner, contiguous to the product name, Flavoring Added’’ or ‘‘Smoke Fla- the statement, ‘‘Tenderized with (name voring Added,’’ as applicable, and the of approved inorganic chloride(s))’’ to ingredient statement shall identify any indicate the use of such inorganic artificial smoke flavoring or smoke fla- chlorides. Any other approved sub- voring added as an ingredient in the stance which may be used in the solu- formula of the poultry product. tion shall also be included in the state- (b) Any poultry product which bears ment. or contains any artificial flavoring [37 FR 9706, May 16, 1972, as amended at 45 other than an artificial smoke fla- FR 58820, Sept. 5, 1980; 49 FR 18999, May 4, voring or a smoke flavoring, or bears 1984; 64 FR 72175, Dec. 23, 1999]

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§ 381.121 Quantity of contents. in section 381.121b of this subchapter, (a) The label shall bear a statement may be printed adjacent to the state- of the quantity of contents in terms of ment of net quantity of contents when weight or measures as provided in the product is packaged totally with paragraph (c)(5) of this section. How- impervious packaging material and is ever, the Administrator may approve packed with a usable medium. the use of labels for certain types of (2) The statement shall be placed on consumer packages which do not bear a the principal display panel within the statement of the net weight that would bottom 30 percent of the area of the otherwise be required under this sub- panel, in lines generally parallel to the paragraph: Provided, That the shipping base: Provided, That on packages hav- container bears a statement ‘‘Net ing a principal display panel of 5 square weight to be marked on consumer inches or less, the requirement for packages prior to display and sale’’: placement within the bottom 30 per- And provided further, That the total net cent of the area of the label panel shall weight of the contents of the shipping not apply when the statement meets container is marked on such container: the other requirements of this para- And provided further, That the shipping graph. The declaration may appear in container bears a statement ‘‘Tare more than one line. weight of consumer package’’ and in (3) The statement shall be in letters close proximity thereto, the actual and numerals in type size established tare weight (weight of packaging mate- in relationship to the area of the prin- rial), weighed to the nearest one-eighth cipal display panel of the package and ounce or less, of the individual con- shall be uniform for all packages of sumer package in the shipping con- substantially the same size by com- tainer. The above-specified statements plying with the following type speci- may be added to approved shipping fications: container labels upon approval by the (i) Not less than one-sixteenth inch inspector in charge. in height on containers, the principal (b) When a poultry product and a display panel of which has an area of 5 nonpoultry product are separately square inches or less; wrapped and are placed in a single im- (ii) Not less than one-eighth inch in mediate container bearing the same height on containers, the principal dis- name of both products, the net weight play panel of which has an area of more on such immediate container may be than 5 but not more than 25 square the total net weight of the products, or inches; such immediate container may show (iii) Not less than three-sixteenth the net weights of the poultry product inch in height on containers, the prin- and the nonpoultry product separately. cipal display panel of which has an Notwithstanding the other provisions area of more than 25 but not more than of this paragraph, the label on con- 100 square inches; sumer size retail packages of stuffed (iv) Not less than one-quarter inch in poultry and other stuffed poultry prod- height on containers, the principal dis- ucts must show the total net weight of play panel of which has an area of more the poultry product, and in close prox- than 100 but not more than 400 square imity thereto, a statement specifying inches; the minimum weight of the poultry in (v) Not less than one-half inch in the product. height on containers, the principal dis- (c)(1) The statement of net quantity play panel of which has an area of more of contents shall appear (except as oth- than 400 square inches. erwise permitted under this paragraph (vi) The ratio of height to width of (c)), on the principal display panel of letters and numerals shall not exceed a all containers to be sold at retail in- differential of 3 units to 1 unit (no tact, in conspicuous and easily legible more than 3 times as high as it is boldface print or type, in distinct con- wide). This height standard pertains to trast to other matter on the container, upper case or capital letters. When and shall be declared in accordance upper and lower case or all lower case with the provisions of this paragraph letters are used, it is the lower case (c). An unused tare weight, as defined letter ‘‘o’’ or its equivalent that shall

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meet the minimum standards. When pound, for packages over 1 pound, and fractions are used, each component nu- for packages which do not exceed 1 meral shall meet one-half the height pound the statement may be in decimal standards. fractions of the pound in lieu of ounces. (4) The statement shall appear as a The numbers may be written in pro- distinct item on the principal display vided the unit designation is printed. panel and shall be separated, from Paragraphs (c) (8) and (9) of this sec- other label information appearing to tion permit certain exceptions to this the left or right of the statement, by a paragraph for multi-unit packages, and space at least equal in width to twice random weight consumer size and the width of the letter ‘‘N’’ of the style small packages (less than 1⁄2 ounce), re- of type used in the quantity of con- spectively. tents statement and shall be separated (6) The statement as it is shown on a from other label information appearing label shall not be false or misleading above or below the statement by a and shall express an accurate state- space at least equal in height to the ment of the quantity of contents of the height of the lettering used in the container. Reasonable variations statement. caused by loss or gain of moisture dur- (5) The terms ‘‘net weight’’ or ‘‘net ing the course of good distribution wt.’’ shall be used when stating the net practices or by unavoidable deviations quantity of contents in terms of in good manufacturing practices will weight, and the term ‘‘net contents’’ or be recognized. Variations from stated ‘‘contents’’ when stating the net quan- quantity of contents shall be as pro- tity of contents in terms of fluid meas- vided in section 381.121b of this sub- ure. Except as provided in § 381.128, the chapter. The statement shall not in- statement shall be expressed in terms clude any term qualifying a unit of of avoirdupois weight or liquid meas- weight, measure, or count such as ure. Where no general consumer usage ‘‘jumbo quart,’’ ‘‘full gallon,’’ ‘‘giant to the contrary exists, the statement quart,’’ ‘‘when packed,’’ ‘‘minimum,’’ shall be in terms of liquid measure, if or words of similar importance except the product is liquid, or in terms of as provided in paragraph (b) of this sec- weight if the product is solid, semi- tion. solid, viscous or a mixture of solid and liquid. On packages containing less (7) Labels for containers which bear than 1 pound or 1 pint, the statement any representation as to the number of shall be expressed in ounces or frac- servings contained therein shall bear, tions of a pint, respectively. On pack- contiguous to such representation, and ages containing 1 pound or 1 pint or in the same size type as is used for more, and less than 4 pounds or 1 gal- such representation, a statement of the lon, the statement shall be expressed net quantity of each such serving. as a dual declaration both in ounces (8) On a multiunit retail package, a and (immediately thereafter in paren- statement of the quantity of contents thesis) in pounds, with any remainder shall appear on the outside of the pack- in terms of ounces or common or dec- age and shall include the number of in- imal fraction of the pound, or in the dividual units, the quantity of each in- case of liquid measure, in the largest dividual unit, and, in parentheses, the whole units with any remainder in total quantity of contents of the multi- terms of fluid ounces or common or unit package in terms of avoirdupois or decimal fraction of the pint or quart. fluid ounces, except that such declara- For example, a declaration of three- tion of total quantity need not be fol- fourths pound avoirdupois weight shall lowed by an additional parenthetical be expressed as ‘‘Net Wt. 12 oz.’’; a dec- declaration in terms of the largest laration of 11⁄2 pounds avoirdupois whole units and subdivisions thereof, weight shall be expressed as ‘‘Net Wt. as otherwise required by this para- 24 oz. (1 lb. 8 oz.),’’ ‘‘Net Wt. 24 oz. (11⁄2 graph (c). ‘‘A multiunit retail package’’ lb.),’’ or ‘‘Net Wt. 24 oz. (1.5 lbs.).’’ How- is a package containing two or more ever, on random weight packages the individually packaged units of the statement shall be expressed in terms identical commodity and in the same of pounds and decimal fractions of the quantity, with the individual packages

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intended to be sold as part of the mul- weight bearing labels declaring net tiunit retail package but capable of weight, price per pound, and total being sold individually. Open multiunit price, shall be exempt from the type retail packages that do not obscure the size, dual declaration, and placement number of units and the labeling there- requirements of this paragraph if an on are not subject to this paragraph (c) accurate statement of net weight is (8) if the labeling of each individual shown conspicuously on the principal unit complies with the requirements of display panel of the package. this paragraph (c). (10) As used in this section a ‘‘ran- (9) The following exemptions from dom weight consumer size package’’ is the requirements contained in this sec- one of a lot, shipment or delivery of tion are hereby established: packages of the same product, with (i) Individually wrapped, random weight consumer size packages of poul- varying weights and with no fixed try products (as specified in paragraph weight pattern. (c)(10) of this section) and poultry prod- [37 FR 9706, May 16, 1972, as amended at 39 ucts that are subject to shrinkage FR 4569, Feb. 5, 1974; 53 FR 28635, July 29, through moisture loss during good dis- 1988; 55 FR 49835, Nov. 30, 1990] tribution practices and are designated as gray area type of products as defined §§ 381.121a–381.121e [Reserved] in NBS handbook 133, section 3.18.2, need not bear a net weight statement § 381.122 Identification of manufac- when shipped from an official estab- turer, packer or distributor. lishment provided a net weight ship- The name and address, including zip ping statement which meets the re- code, of the manufacturer, packer, or quirements of paragraph (c)(6) of this distributor shall be shown on the label section is applied to the shipping con- and if only the name and address of the tainer prior to shipping it from the of- distributor is shown, it shall be quali- ficial establishment. Net weight state- fied by such term as ‘‘packed for,’’ ments so applied to the shipping con- ‘‘distributed by,’’ or ‘‘distributors.’’ tainer are exempt from the type size, The name and place of business of the dual declaration, and placement re- manufacturer, packer, or distributor quirements of this paragraph if an ac- may be shown on the principal display curate statement of net weight is panel, on the 20-percent panel of the shown conspicuously on the principal display panel of the shipping container. principal display panel reserved for re- The net weight also shall be applied di- quired information, on the front riser rectly to random weight consumer size panel of frozen food cartons, or on the packages prior to retail display and information panel. sale. The net weight statement of ran- [37 FR 9706, May 16, 1972, as amended at 59 dom weight consumer size packages for FR 40215, Aug. 8, 1994] retail sale shall be exempt from the type size, dual declaration, and place- § 381.123 Official inspection mark; offi- ment requirements of this paragraph if cial establishment number. an accurate statement of net weight is The immediate container of every in- shown conspicuously on the principal spected and passed poultry product display panel of the package. shall bear: (ii) Individually wrapped and labeled (a) The official inspection legend; and packages of less than 1⁄2 ounce net weight and random weight consumer (b) The official establishment num- size packages shall be exempt from the ber of the official establishment in requirements of this paragraph if they which the product was processed under are in a shipping container and the inspection and placed as follows: statement of net quantity of contents (1) Within the official inspection leg- on the shipping container meets the re- end in the form required by subpart M quirements of paragraph (c)(6) of this of this part; or section; (2) Outside the official inspection leg- (iii) Individually wrapped and labeled end elsewhere on the exterior of the packages of less than 1⁄2 ounce net container or its labeling, e.g., the lid of

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a can, if shown in a prominent and leg- tainers having a net weight of 3 pounds ible manner in a size sufficient to in- or less, and for containers having a net sure easy visibility and recognition and weight over 3 pounds, the statement accompanied by the prefix ‘‘P’’; or shall be shown in letters one-half inch (3) Off the exterior of the container, in height. e.g., on a metal clip used to close cas- (b) Safe handling instructions shall ings or bags, or on the back of a paper be provided for all poultry products not label of a canned product, or on other processed in accordance with the provi- packaging or labeling in the container, sions of § 381.150(a) or that have not un- e.g., on aluminum pans and trays dergone other processing that would placed within containers, when a state- render them ready-to-eat, except as ex- ment of its location is printed contig- empted under paragraph (b)(4) of this uous to the official inspection legend, section. such as ‘‘Plant No. on Package Clo- (1) (i) Safe handling instructions sure’’ or ‘‘Plant No. on Pan’’, if shown shall accompany the poultry products, in a prominent and legible manner in a specified in this paragraph (b), destined size sufficient to ensure easy visibility for household consumers, hotels, res- and recognition; or taurants, or similar institutions and (4) On an insert label placed under a shall appear on the label. The informa- transparent covering if clearly visible tion shall be in lettering no smaller and legible and accompanied by the than one-sixteenth of an inch in size prefix ‘‘P’’. and shall be prominently placed with [47 FR 29515, July 7, 1982] such conspicuousness (as compared with other words, statements, designs § 381.124 Dietary food claims. or devices in the labeling) as to render If a product purports to be or is rep- it likely to be read and understood by resented for any special dietary use by the ordinary individual under cus- man, its label shall bear a statement tomary conditions of purchase and use. concerning its vitamin, mineral, and (ii) The safe handling information other dietary properties upon which shall be presented on the label under the claim for such use is based in whole the heading ‘‘Safe Handling Instruc- or in part and shall be in conformity tions’’ which shall be set in type size with regulations (21 CFR part 125) es- larger than the print size of the ration- tablished pursuant to sections 403 and ale statement and handling statements 701 of the Federal Food, Drug, and Cos- as discussed in paragraphs (b)(2) and metic Act (21 U.S.C. 343, 371). (b)(3) of this section. The safe handling information shall be set off by a border § 381.125 Special handling label re- and shall be one color type printed on quirements. a single color contrasting background (a) Packaged products which require whenever practical. special handling to maintain their (2) (i) The labels of the poultry prod- wholesome condition shall have promi- ucts, specified in this paragraph (b) and nently displayed on the principal dis- prepared from inspected and passed play panel of the label the statement: poultry, shall include the following ra- ‘‘Keep Refrigerated,’’ ‘‘Keep Frozen,’’ tionale statement as part of the safe ‘‘Keep Refrigerated or Frozen,’’ ‘‘Per- handling instructions, ‘‘This product ishable—Keep Under Refrigeration,’’ or was prepared from inspected and passed such similar statement as the Adminis- meat and/or poultry. Some food prod- trator may approve in specific cases. ucts may contain bacteria that could The immediate containers for products cause illness if the product is mis- that are frozen during distribution and handled or cooked improperly. For intended to be thawed prior to or dur- your protection, follow these safe han- ing display for sale shall bear the dling instructions.’’ This statement statement ‘‘Shipped/Stored and Han- shall be placed immediately after the dled Frozen for Your Protection, Keep heading and before the safe handling Refrigerated or Freeze.’’ For all canned statements. perishable products, the statement (ii) The labels of the poultry prod- shall be shown in upper case letters ucts, specified in this paragraph (b) and one-fourth inch in height for con- prepared pursuant to § 381.10(a) (2), (5),

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(6), and (7), shall include the following (b) The immediate container for rationale statement as part of the safe dressed poultry shall be marked with a handling instructions, ‘‘Some food lot number which shall be the number products may contain bacteria that of the day of the year on which the could cause illness if the product is poultry was slaughtered or a coded mishandled or cooked improperly. For number. your protection, follow these safe han- (c) All canned products shall be dling instructions.’’ This statement plainly and permanently marked, by shall be placed immediately after the code or otherwise, on the containers, heading and before the safe handling with the identity of the contents and statements. date of canning, except that canned (3) Poultry products, specified in this products packed in glass containers are paragraph (b), shall bear the labeling not required to be marked with the statements. date of canning if such information ap- (i) Keep refrigerated or frozen. Thaw pears on the shipping container. If cal- in refrigerator or microwave. (Any por- endar dating is used, it must be accom- tion of this statement that is in con- panied by an explanatory statement, as flict with the product’s specific han- provided in § 381.129(c)(2). dling instructions may be omitted, e.g., (d) If any marking is by code, the in- instructions to cook without thawing.) spector in charge shall be informed as (A graphic illustration of a refrigerator to its meaning. shall be displayed next to the state- [37 FR 9706, May 16, 1972, as amended at 39 ment.); FR 28516, Aug. 8, 1974; 39 FR 35784, Oct. 4, (ii) Keep raw meat and poultry sepa- 1974] rate from other foods. Wash working surfaces (including cutting boards), § 381.127 Wording on labels of ship- utensils, and hands after touching raw ping containers. meat or poultry. (A graphic illustra- (a) Each label for use on a shipping tion of soapy hands under a faucet container for inspected and passed shall be displayed next to the state- poultry products shall bear, in dis- ment.); tinctly legible form, the following in- (iii) Cook thoroughly. (A graphic il- formation: lustration of a skillet shall be dis- (1) The official inspection legend. played next to the statement.); and (2) The official establishment number (iv) Keep hot foods hot. Refrigerate of the official establishment in which leftovers immediately or discard. (A the poultry product was inspected, ei- graphic illustration of a thermometer ther within the official inspection shall be displayed next to the state- mark, or elsewhere on the container ment.) clearly visible and in proximity to the (4) Poultry products intended for fur- official inspection mark. ther processing at another official establishment are exempt from the re- § 381.128 Labels in foreign languages. quirements prescribed in paragraphs Any label to be affixed to a container (b)(1) through (b)(3) of this section. of any dressed poultry or other poultry [37 FR 9706, May 16, 1972, as amended at 39 product for foreign commerce may be FR 4569, Feb. 5, 1974; 59 FR 14540, Mar. 28, printed in a foreign language. However, 1994; 64 FR 746, Jan. 6, 1999] the official inspection legend and establishment number shall appear on § 381.126 Date of packing and date of the label in English, but in addition, processing; contents of cans. may be literally translated into such (a) Either the immediate container foreign language. Each such label shall or the shipping container of all poultry be subject to the applicable provisions food products shall be plainly and per- of §§ 381.115 to 381.141, inclusive. Devi- manently marked by code or otherwise ations from the form of labeling re- with the date of packing. If calendar quired under the regulations may be dating is used, it must be accompanied approved by the Administrator in spe- by an explanatory statement, as pro- cific cases and such modified labeling vided in § 381.129(c)(2). may be used for poultry products to be

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exported: Provided, (a) That the pro- and whose component parts can be eas- posed labeling accords to the specifica- ily separated at time of packing. tions of the foreign purchaser, (b) that (4) Poultry products labeled with a it is not in conflict with the Act or the term quoted in any paragraph of laws of the country to which it is in- § 381.170(b) shall comply with the speci- tended for export, and (c) that the out- fications in the applicable paragraph. side of the shipping container is la- However, parts of poultry may be cut beled to show that it is intended for ex- in any manner the processor desires as port; but if such product is sold or of- long as the labeling appropriately re- fered for sale in domestic commerce, flects the contents of the container of all the requirements of the regulations such poultry. shall apply. (5) The terms ‘‘All,’’ ‘‘Pure,’’ ‘‘100%,’’ and terms of similar connotation shall § 381.129 False or misleading labeling not be used on labels for products to or containers. identify ingredient content, unless the (a) No poultry product subject to the product is prepared solely from a single Act shall have any false or misleading ingredient. labeling or any container that is so (6)(i) A raw poultry product whose in- made, formed, or filled as to be mis- ternal temperature has ever been below leading. However, established trade 26 °F may not bear a label declara- names and other labeling and con- tion of ‘‘fresh.’’ A raw poultry product tainers which are not false or mis- bearing a label declaration of ‘‘fresh’’ leading and which are approved by the but whose internal temperature has Administrator in the regulations or in ever been below 26 °F is mislabeled. specific cases are permitted. The temperature of individual pack- (b) No statement, word, picture, de- ages of raw poultry product within an sign, or device which is false or mis- official establishment may deviate leading in any particular or conveys below the 26 °F standard by 1 degree any false impression or gives any false (i.e., have a temperature of 25 °F) and indication of origin, identity, or qual- still be labeled ‘‘fresh.’’ The tempera- ity, shall appear on any label. For ex- ture of individual packages of raw ample: poultry product outside an official es- (1) Official grade designations such as tablishment may deviate below the 26 the letter grades A, B, and C may be °F standard by 2 degrees (i.e., have a used in labeling individual carcasses of temperature of 24 °F) and still be la- poultry or containers of poultry prod- beled ‘‘fresh.’’ The average tempera- ucts only if such articles have been ture of poultry product lots of each graded by a licensed grader of the Fed- specific product type must be 26 °F. eral or Federal-State poultry grading Product described in this paragraph is service and found to qualify for the in- not subject to the freezing procedures dicated grade. required in § 381.66(f)(2) of this sub- (2) Terms having geographical sig- chapter. nificance with reference to a particular (ii) Raw poultry product whose inter- locality may be used only when the nal temperature has ever been at or product was produced in that locality. below 0°F must be labeled with the de- (3) ‘‘Fresh frozen’’, ‘‘quick frozen’’, scriptive term ‘‘frozen,’’ except when ‘‘frozen fresh’’, and terms of similar such labeling duplicates or conflicts import apply only to ready-to-cook with the labeling requirements in poultry processed in accordance with § 381.125 of this subchapter. The word § 381.66(f)(1). Ready-to-cook poultry ‘‘previously’’ may be placed next to the handled in any other manner and term ‘‘frozen’’ on an optional basis. dressed poultry may be labeled ‘‘fro- The descriptive term must be promi- zen’’ only if it is frozen in accordance nently displayed on the principal dis- with § 381.66(f)(2) under Department su- play panel of the label. If additional la- pervision and is in fact in a frozen beling containing the descriptive term state. ‘‘Individually quick frozen is affixed to the label, it must be (Kind)’’ and terms of similar import prominently affixed to the label. The are applicable only to poultry products additional labeling must be so con- that are frozen as stated on the label spicuous (as compared with other

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words, statements, designs, or devices copy of the authorization record upon in the labeling) that it is likely to be request. read and understood by the ordinary (B) Upon the arrival of the shipment individual under customary conditions at the official establishment, a careful of purchase and use. Product described inspection shall be made of the product in this paragraph is subject to the by the inspector, and if it is found that freezing procedures required in the product is not adulterated, it may § 381.66(f)(2) of this subchapter. be received into the establishment; but (iii) Raw poultry product whose in- if the product is found to be adulter- ternal temperature has ever been below ated, it shall at once be condemned and 26 °F, but is above 0 °F, is not required disposed of in accordance with § 381.95 to bear any specific descriptive term. of this subchapter. Wholesome product Raw poultry product whose internal will be relabeled in accordance with temperature has ever been below 26 °F, paragraph (b)(6) (i) or (ii) of this sec- but is above 0 °F, may bear labeling tion, as appropriate. with an optional, descriptive term, pro- (C) When any inspected and passed vided the optional, descriptive term product has become misbranded under does not cause the raw poultry product this subpart after it has been trans- to become misbranded. If used, an op- ported from an official establishment, tional, descriptive term must be promi- the owner may transport the product nently displayed on the principal dis- in commerce to a retail entity for re- play panel of the label. If additional la- labeling in accordance with paragraph beling containing the optional, descrip- (b)(6) (i) or (ii) of this section, as appro- tive term is affixed to the label, it priate, or to other end users, such as must be prominently affixed on the hotels, restaurants or similar institu- label. The additional labeling must be tions; or, relabel the product in accord- so conspicuous (as compared with other ance with paragraph (b)(6) (i) or (ii) of words, statements, designs, or devices this section, as appropriate if the prod- in the labeling) that it is likely to be uct is already at a retail entity. A read and understood by the ordinary hotel, restaurant or similar institution individual under customary conditions is not required to relabel product mis- of purchase and use. branded under this subpart; Provided, (iv) Handling and relabeling of prod- That the product is prepared in meals ucts. (A) Except as provided under para- or as entrees only for sale or service di- graph (b)(6)(iii)(C) of this section, when rectly to individual consumers at such any inspected and passed product has institutions, and that the mark of in- become misbranded under this subpart spection is removed or obliterated. after it has been transported from an Oral permission shall be obtained from official establishment, such product the Area Officer-in-Charge of the Com- may be transported in commerce to an pliance Program for the area in which official establishment after oral per- the product is located prior to such mission is obtained from the Area Su- transportation or relabeling. The Area pervisor of the area in which that offi- Officer-in-Charge shall record the au- cial establishment is located. The thorization and other information nec- transportation of the product may be essary to identify the product, and to the official establishment from shall furnish a copy of the authoriza- which it had been transported or to an- tion record upon request. Before being other official establishment designated offered for sale at a retail entity, such by the person desiring to handle the product shall be relabeled. product. The transportation shall be (v) Ready-to-cook chicken may bear authorized only for the purpose of the the claim ‘‘air chilled’’ or ‘‘air relabeling of the product. The Area Su- chilling’’ on its label only if the prod- pervisor shall record the authorization uct was chilled under a process that and other information necessary to meets the definition of air chilling in identify the product and shall provide a § 381.66(e). copy of the record to the inspector at (c) A calendar date may be shown on the establishment receiving the prod- labeling when declared in accordance uct. The shipper shall be furnished a with the provisions of this paragraph:

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(1) The calendar date shall express § 381.130 False or misleading labeling the month of the year and the day of or containers; orders to withhold the month for all products and also the from use. year in the case of products hermeti- If the Administrator has reason to cally sealed in metal or glass con- believe that any marking or other la- tainers, dried or frozen products, or beling or the size or form of any con- any other products that the Adminis- tainer in use or proposed for use with trator finds should be labeled with the respect to any article subject to the year because the distribution and mar- Act is false or misleading in any par- keting practices with respect to such ticular, he may direct that the use of products may cause a label without a the article be withheld unless it is year identification to be misleading. modified in such manner as the Admin- (2) Immediately adjacent to the cal- istrator may prescribe so that it will endar date will be a phrase explaining not be false or misleading. If the person the meaning of such date in terms of using or proposing to use the labeling ‘‘packing’’ date, ‘‘sell by’’ date, or ‘‘use or container does not accept the deter- before’’ date, with or without a further mination of the Administrator, he may qualifying phrase, e.g., ‘‘For Maximum request a hearing, but the use of the la- Freshness’’ or ‘‘For Best Quality.’’ beling or container shall, if the Admin- (d) When sodium alginate, calcium istrator so directs, be withheld pending carbonate, lactic acid, and calcium lac- hearing and final determination by the tate are used together in a dry binding Secretary in accordance with applica- matrix in ground or formed poultry ble rules of practice. Any such deter- products, as permitted in § 424.21(c) of mination with respect to the matter by subchapter E, there shall appear on the the Secretary shall be conclusive un- label contiguous to the product name a less, within 30 days after the receipt of statement to indicate the use of so- notice of such final determination, the dium alginate, calcium carbonate, lac- person adversely affected thereby ap- tic acid, and calcium lactate. peals to the U.S. Court of Appeals for (e) When transglutaminase enzyme is the Circuit in which he has his prin- used to bind pieces of poultry to form cipal place of business, or to the U.S. a cut of poultry, or to reform a piece of Court of Appeals for the District of Co- poultry from a multiple cuts of poul- lumbia Circuit. The provisions of sec- try, there shall appear on the label, as tion 204 of the Packers and Stockyards part of the product name, a statement Act of 1921, as amended, shall be appli- that indicates that the product has cable to appeals taken under this sec- been ‘‘formed’’ or ‘‘reformed,’’ in addition. tion to other preparation steps, e.g., ‘‘Formed Turkey Thigh Roast’’ or § 381.131 Preparation of labeling or other devices bearing official in- ‘‘Reformed and Shaped Chicken spection marks without advance ap- Breast.’’ proval prohibited; exceptions. (f) A country of origin statement on (a) Except for the purposes of pre- the label of any poultry product ‘‘cov- paring and submitting a sample or ered commodity’’ as defined in 7 CFR samples of the same to the Adminis- part 65, subpart A, that is to be sold by trator for approval, no brand manufac- a ‘‘retailer,’’ as defined in 7 CFR 65.240, turer, printer, or other person shall must comply with the requirements in cast, print, lithograph, or otherwise 7 CFR 65.300 and 65.400. make any marking device containing [37 FR 9706, May 16, 1972, as amended at 39 any official mark or simulation there- FR 28516, Aug. 8, 1974; 39 FR 42339, Dec. 5, of, or any label bearing any such mark 1974; 55 FR 5977, Feb. 21, 1990; 60 FR 44412, or simulation, without the written au- Aug. 25, 1995; 61 FR 66200, Dec. 17, 1996; 61 FR thority therefor of the Administrator. 68821, Dec. 30, 1996; 66 FR 54916, Oct. 31, 2001; However, when any such sample label, 73 FR 50703, Aug. 28, 2008; 76 FR 82078, Dec. 30, or other marking device, is approved 2011; 78 FR 66838, Nov. 7, 2013; 79 FR 49637, Aug. 21, 2014] by the Administrator, additional supplies of the approved label, or marking

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device, may be made for use in accord- mark such marking device with a per- ance with the regulations in this sub- manent identifying number. chapter, without further approval by (Recordkeeping requirements approved by the Administrator. The provisions of the Office of Management and Budget under this paragraph do not apply to marking control number 0583–0015) devices containing the official inspec- [50 FR 21423, May 24, 1985] tion legend shown in Figure 5 of § 381.102. §§ 381.132–381.133 [Reserved] (b) No brand manufacturer or other person shall cast or otherwise make, § 381.134 Requirement of formulas. without an official certificate issued in Copies of each label submitted for ap- quadruplicate by a Program employee, proval, shall when the Administrator a marking device containing the offi- requires in any specific case, be accom- cial inspection legend shown in Figure panied by a statement showing, by 5 of § 381.102 or any simulation of that their common or usual names, the legend. kinds and percentages of the ingredi- (1) The certificate is a Food Safety ents comprising the poultry product and Inspection Service form for signa- and by a statement indicating the ture by a Program employee and the method or preparation of the product official establishment ordering the with respect to which the label is to be marking device, bearing a certificate used. Approximate percentages may be serial number and a letterhead and the given in cases where the percentages of seal of the United States Department ingredients may vary from time to of Agriculture. The certificate author- time, if the limits of variation are stat- izes the making of only the devices of ed. the type and quantity listed on the cer- [37 FR 9706, May 16, 1972, as amended at 39 tificate. FR 4569, Feb. 5, 1974; 59 FR 45196, Sept. 1, (2) After signing the certificate, the 1994. Redesignated at 60 FR 67457, Dec. 29, Program employee and the establish- 1995] ment shall each keep a copy, and the § 381.136 Affixing of official identifica- remaining two copies shall be given to tion. the marking device manufacturer. (3) The manufacturer of the marking (a) No official inspection legend or devices shall engrave or otherwise any abbreviation or other simulation mark each marking device with a per- thereof may be affixed to or placed on or caused to be affixed to or placed on manent identifying serial number any poultry product or container unique to it. The manufacturer shall thereof, except by an inspector or list on each of the two copies of the under the supervision of an inspector certificate given to the manufacturer or other person authorized by the Ad- the number of each marking device au- ministrator, and no container bearing thorized by the certificate. The manu- any such legend shall be filled except facturer shall retain one copy of the under such supervision. certificate for the manufacturer’s (b) No official inspection legend shall records and return the remaining copy be used on any poultry product or with the marking devices to the Pro- other article which does not qualify for gram employee whose name and ad- such mark under the regulations. dress are given on the certificate as the recipient. § 381.137 Evidence of labeling and de- (4) In order that all such marking devices approval. vices bear identifying numbers, within No inspector shall authorize the use one year after June 24, 1985, an estab- of any device bearing any official in- lishment shall either replace each such spection legend unless he or she has on marking device that does not bear an file evidence that such device has been identifying number, or, under the di- approved in accordance with the provi- rection of the inspector-in-charge, sions of this subpart. [60 FR 67458, Dec. 29, 1995]

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§ 381.138 Unauthorized use or disposi- than an official establishment, is in tion of approved labeling or de- need of relabeling because the labeling vices. has become mutilated or damaged, or (a) Labeling and devices approved for for some other reason needs relabeling, use pursuant to § 381.115 shall be used the requests for relabeling the poultry only for the purpose for which ap- product shall be sent to the Adminis- proved, and shall not be disposed of trator and accompanied with a state- from the official establishment for ment of the reasons therefor and the which approved except with written ap- quantity of labeling required. Labeling proval of the Administrator. Any unau- material intended for relabeling in- thorized use or disposition of approved spected and passed product shall not be labeling or devices bearing official in- transported from an official establish- spection marks is prohibited and may ment until permission has been re- result in cancellation of the approval. ceived from the Administrator. The re- (b) Labeling and containers bearing labeling of inspected and passed prod- any official inspection marks, with or uct with official labels shall be done without the official establishment under the supervision of an inspector number, may be transported from one pursuant to the regulations in part 362 official establishment to any other of- of this chapter. The establishment ficial establishment, only if such ship- shall reimburse the Inspection Service ments are made with the prior author- for any cost involved in supervising the ization of the inspector in charge at relabeling of such product as provided point of origin, who will notify the in- in said regulations. spector in charge at destination concerning the date of shipment, quantity, §§ 381.141–381.143 [Reserved] and type of labeling material involved. Approved labeling and containers may § 381.144 Packaging materials. be moved without restriction under (a) Edible products may not be pack- this part between official establish- aged in a container which is composed ments operated by the same person if in whole or in part of any poisonous or such labeling and containers are ap- deleterious substances which may proved for use at all such establish- render the contents adulterated or in- ments. No such material shall be used jurious to health. All packaging mate- at the establishment to which it is rials must be safe for the intended use shipped unless such use conforms with within the meaning of section 409 of the requirements of this subpart. the Federal Food, Drug, and Cosmetic Act, as amended (FFDCA). § 381.139 Removal of official identifica- (b) Packaging materials entering the tions. official establishment must be accom- (a) Every person who receives any panied or covered by a guaranty, or poultry product in containers which statement of assurance, from the pack- bear any official inspection legend aging supplier under whose brand name shall remove or deface such legend or and firm name the material is mar- destroy the containers upon removal of keted to the official establishment. such articles from the containers. The guaranty shall state that the ma- (b) No person shall alter, detach, de- terial’s intended use complies with the face, or destroy any official identifica- FFDCA and all applicable food additive tions prescribed in subpart M that were regulations. The guaranty must iden- applied pursuant to the regulations, tify the material, e.g., by the distin- unless he is authorized to do so by an guishing brand name or code designa- inspector or this section; and no person tion appearing on the packaging mate- shall fail to use any such official iden- rial shipping container; must specify tification when required by this part. the applicable conditions of use, including temperature limits and other § 381.140 Relabeling poultry products. pertinent limits specified under the When it is claimed by the operator of FFDCA and food additive regulations; an official establishment that some of and must be signed by an authorized its labeled poultry product, which has official of the supplying firm. The been transported to a location other guaranty may be limited to a specific

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shipment of an article, in which case it nied. The Administrator may extend may be part of or attached to the in- this time where reasonable grounds for voice covering such shipment, or it extension are shown, as, for example, may be general and continuing, in where data must be obtained from sup- which case, in its application to any pliers. article or other shipment of an article, (e) The Administrator may dis- it shall be considered to have been approve for use in official establish- given at the date such article was ments packaging materials whose use shipped by the person who gives the cannot be confirmed as complying with guaranty. Guaranties consistent with the FFDCA and applicable food addi- the Food and Drug Administration’s tive regulations. Before approval to use regulations regarding such guaranties a packaging material is finally denied (21 CFR 7.12 and 7.13) will be acceptable. The management of the establish- by the Administrator, the affected offi- ment must maintain a file containing cial establishment and the supplier of guaranties for all food contact pack- the material shall be given notice and aging materials in the establishment. the opportunity to present their views The file shall be made available to Pro- to the Administrator. If the official es- gram inspectors or other Department tablishment and the supplier do not ac- officials upon request. While in the of- cept the Administrator’s determina- ficial establishment, the identity of all tion, a hearing in accordance with ap- packaging materials must be traceable plicable rules of practice will be held to to the applicable guaranty. resolve such dispute. Approval to use (c) The guaranty by the packaging the materials pending the outcome of supplier will be accepted by Program the presentation of views or hearing inspectors to establish that the use of shall be denied if the Administrator de- material complies with the FFDCA and termines that such use may present an all applicable food additive regula- imminent hazard to public health. tions. (f) Periodically, the Administrator (d) The Department will monitor the will issue to inspectors a listing, by use of packaging materials in official distinguishing brand name or code des- establishments to assure that the re- ignation, of packaging materials that quirements of paragraph (a) of this sec- have been reviewed and that fail to tion are met, and may question the meet the requirements of paragraph (a) basis for any guaranty described under of this section. Listed materials will paragraph (b) of this section. Official establishments and packaging sup- not be permitted for use in official es- pliers providing written guaranties to tablishments. If a subsequent review of those official establishments will be any material indicates that it meets permitted an opportunity to provide the requirements of paragraph (a), the information to designated Department material will be deleted from the list- officials as needed to verify the basis ing. for any such guaranty. The required in- (g) Nothing in this section shall af- formation will include, but is not lim- fect the authority of Program inspec- ited to, manufacturing firm’s name, tors to refuse a specific material if he/ trade name or code designation for the she determines the material may material, complete chemical composi- render products adulterated or inju- tion, and use. Selection of a material rious to health. for review does not in itself affect a material’s acceptability. Materials [49 FR 2236, Jan. 19, 1984] may continue to be used during the review period. However, if information requested from the supplier is not provided within the time indicated in the request—a minimum of 30 days—any applicable guaranty shall cease to be effective and approval to continue using the specified packaging material in official establishments may be de-

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Subpart O—Entry of Articles Into spected poultry products and proc- Official Establishments; Proc- essing and other operations with re- essing Inspection and Other spect thereto from the exempted arti- Reinspections; Processing Re- cles and operations with respect there- quirements to, complete cleanup of facilities and equipment between processing of in- § 381.145 Poultry products and other spected poultry products and the ex- articles entering or at official estab- empted articles and no commingling of lishments; examination and other inspected and exempted articles in re- requirements. ceiving, holding or storage areas. (a) No poultry product (including (b) All poultry products and all car- poultry broth for use in any poultry casses, parts thereof, meat and meat product in any official establishment) food products of cattle, sheep, swine, may be brought into any official estab- goats, or equines which enter any offi- lishment unless it has been processed cial establishment shall be identified in the United States only in an official by the operator of the official estab- establishment or imported from a for- lishment at the time of receipt at the eign country listed in § 381.196(b), and inspected and passed, in accordance official establishment. All poultry with the regulations; and unless the products, and all carcasses, parts container of such product is marked so thereof, meat and meat food products as to identify the product as so in- of such animals, which are processed or spected and passed, in accordance with otherwise handled at any official estab- § 381.115 or § 381.205, except that poultry lishment shall be subject to examina- products inspected and passed and tion by an inspector at the official es- identified as such under the laws of an tablishment in such manner and at ‘‘at least equal’’ State or territory list- such times as may be deemed necessary ed in § 381.187 may be brought into any by the inspector in charge to assure official establishment solely for stor- compliance with the regulations. Upon age and distribution therefrom without such examination, if any such article repackaging, relabeling, or processing or portion thereof is found to be adul- in such establishment. No carcass, part terated, such article or portion shall, thereof, meat or meat food product of in the case of poultry products, be con- cattle, sheep, swine, goats, or equines demned and disposed of as prescribed in may be brought into an official estab- § 381.95, unless by reprocessing they lishment unless it has been prepared in may be made not adulterated, and the United States only in an official meat packing establishment, or im- shall, in the case of such other articles ported, and inspected and passed, in ac- be disposed of according to applicable cordance with the Federal Meat Inspec- law. tion Act, and the regulations under Such examination may be accom- such Act (Subchapter A of this chap- plished through use of statistically ter) and is properly marked as so in- sound sampling plans that assure a spected and passed; or has been in- high level of confidence. The inspector spected and passed and is identified as in charge shall designate the type of such in accordance with the require- plan and the program employee shall ments of the law and regulations of a select the specific plan to be used in State not designated in § 331.2 of this accordance with instructions issued by chapter; or is present in the official es- the Administrator. 1 tablishment by reason of an exemption allowed in the Federal Meat Inspection Act and the regulations under such Act 1 Further information concerning sampling (Subchapter A of this chapter) or the plans which have been adopted for specific law and regulations of a State not so products may be obtained from the Circuit designated. However, such exempted Supervisor. These sampling plans are devel- articles may enter only under condi- oped for individual products by the Wash- tions approved by the Administrator in ington staff and will be distributed for field specific cases, including but not lim- use as they are developed. The type of plan ited to, complete separation of in- Continued

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(c) Applying for Total Plant Quality also be responsible for the quality con- Control. Any owner or operator of an trol system. official establishment preparing poul- (3) A list identifying those subparts try product who has a total plant qual- and sections of the poultry products in- ity control system or plan for control- spection regulations which are applica- ling such products, after ante-mortem ble to the operations of the establish- and post-mortem inspection, through ment applying for approval of a quality all stages of preparation, may request control system. This list shall also the Administrator to evaluate it to de- identify which part of the system will termine whether or not that system is serve to maintain compliance with the adequate to result in product being in applicable regulations. compliance with the requirements of (4) Detailed information concerning the Act and therefore qualify as a U.S. Department of Agriculture (USDA) the manner in which the system will Total Plant Quality Control Establish- function. Such information should in- ment. Such a request shall, as a min- clude, but not necessarily be limited imum, include: to, questions of raw material control, (1) A letter to the Administrator the critical check or control points, from the establishment owner or oper- the nature and frequency of tests to be ator stating the company’s basis and made, the nature of charts and other purpose for seeking an approved qual- records that will be used, the length of ity control system and willingness to time such charts and records will be adhere to the requirements of the sys- maintained in the custody of the offi- tem as approved by the Department; cial establishment, the nature of defi- that all the establishment’s data, anal- ciencies the quality control system is yses, and information generated by its designed to identify and control, the quality control system will be main- parameters of limits which will be used tained to enable the Department to and the points at which corrective ac- monitor compliance and available to tion will occur, and the nature of such Department personnel; that plant qual- corrective action—ranging from the ity control personnel will have author- least to most severe: Provided, That ity to halt production or shipping of subsequent to approval of the total product in cases where the submitted plant quality control system by the quality control systems require it; and Administrator, the official establish- that the owner or operator (or his/her ment may produce a new product for designee) will be available for consulta- test marketing provided labeling for tion at any time Department personnel the product has been approved by the consider it necessary. Administrator, the inspector in charge (2) In the case of an establishment has determined that the procedures for having one or more full-time persons preparing the product will assure that whose primary duties are related to the quality control system, an organiza- all Federal requirements are met, and tional chart showing that such people the production for test marketing does ultimately report to an establishment not exceed 6 months. Such new product official whose quality control respon- shall not be produced at that establish- sibilities are independent of or not pre- ment after the 6-month period unless dominantly production responsibil- approval of the quality control system ities. In the case of a small establish- for that product has been received from ment which does not have full-time the Administrator. quality control personnel, information (d)–(e) [Reserved] indicating the nature of the duties and (f) Labeling Logo. Owners and opera- responsibilities of the person who will tors of official establishments having a total plant quality control system ap- applicable depends on factors such as wheth- proved under the provisions of para- er the product is in containers, stage of prep- graph (c) of this section may only use, aration, and procedures followed by the es- as a part of any label, the following tablishment operator. The specific plan ap- logo. plicable depends on the kind of product involved.

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within 30 days of the date of the letter. In those instances where there is a conflict of facts, a hearing, under applicable Rules of Practice, will be afforded to the establishment owner or operator, if requested, to resolve the conflict. The Administrator’s termination of quality control approval shall remain in effect pending the final determination of the proceeding. (3) If approval of the total establishment quality control system has been terminated in accordance with the provisions of this section, an application and request for approval of the same or modified total establishment quality control system will not be evaluated by the Administrator for at least 6 (g) Termination of Quality Control Sys- months from the termination date. tems. (1) The approval of a total plant (4) If approval of a quality control quality control system may be termi- system for irradiation facilities, as nated at any time by the owner or op- specified in section 381.149 of this sub- erator of the official establishment part, has been terminated in accord- upon written notice to the Adminis- ance with the provisions of this sec- trator. tion, a request for approval of the same (2) The approval of a total plant qual- or a modified quality control system ity control system or a quality control will be evaluated by the Administrator system for irradiation facilities may be upon receipt. terminated upon the establishment’s (h)(1) Operating Schedule Under Total receipt of a written notice from the Ad- Plant Quality Control. An official estab- ministrator under the following condi- lishment with an approved total plant tions: quality control system may request ap- (i) If adulterated or misbranded poul- proval for an operating schedule of up try product is found by the to 12 consecutive hours per shift. Per- Adminstrator to have been prepared for missions will be granted provided that: or distributed in commerce by the sub- (i) The official establishment has sat- ject establishment. In such case, oppor- isfactorily operated under a total plant tunity will be provided to the estab- quality control system for at least 1 lishment owner or operator to present year. views to the Administrator within 30 (ii) All products prepared and pack- days of the date of terminating the ap- aged, or processed after the end of 8 proval. In those instances where there hours of inspection shall only be a con- is a conflict of facts, a hearing, under tinuation of the processing monitored applicable Rules of Practice, will be af- by the inspector and being conducted forded to the establishment owner or during the last hour of inspection. operator, if requested, to resolve the (iii) All immediate containers of conflict, The Administrator’s termi- products prepared and packaged shall nation of approval shall remain in ef- bear code marks that are unique to any fect pending the final determination of period of production beyond the 8 hours the proceeding. of inspection. The form of such code (ii) If the establishment fails to com- marks will remain constant from day ply with the quality control system to to day, and a facsimile of the code which it has agreed after being notified marks and their meaning shall be pro- by letter from the Administrator or his vided to the inspector. designee. Prior to such termination, (2) Application. Applications shall be opportunity will be provided to the es- submitted to the Regional Director and tablishment owner or operator to shall specify how the conditions in present views to the Administrator § 381.145(h)(1) have been or will be met.

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(3) Monitoring by Inspectors. In order are prepared, except that, upon written to verify that an establishment is pre- request, and under such conditions as paring and shipping product in accord- may be prescribed by the Adminis- ance with the approved total plant trator in specific cases, such products quality control system and the Act and may be moved from the official estab- regulations after the 8 hours of inspec- lishment prior to freezing: Provided, tion, the official establishment may be That the official establishment and provided overtime inspectiom services freezer are so located and the necessary at the discretion of the circuit super- arrangements are made so that the In- visor and charged for such services. spection Service will have access to the (i) To ensure the safe use of prepara- freezing room and adequate oppor- tions used in poultry scald water, the tunity to determine that the products label or labeling on containers of such are being properly handled and frozen. preparations shall bear adequate directions to ensure use in compliance with § 381.150 Requirements for the produc- any limitations prescribed in 21 CFR tion of fully cooked poultry prod- Chapter I, Subchapter A or Subchapter ucts and partially cooked poultry B or 9 CFR Chapter III, Subchapter A breakfast strips. or Subchapter E. (a) Fully cooked poultry products (Recordkeeping requirements approved by must be produced using processes en- the Office of Management and Budget under suring that the products meet the fol- control number 0583–0015) lowing performance standards:

[37 FR 9706, May 16, 1972, as amended at 45 (1) Lethality. A 7-log10 reduction of FR 54323, Aug. 15, 1980; 46 FR 48904, Oct. 5, Salmonella or an alternative lethality 1981; 50 FR 6, Jan. 2, 1985; 51 FR 32304, Sept. that achieves an equivalent probability 11, 1986; 57 FR 43598, Sept. 21, 1992; 62 FR 45026, Aug. 25, 1997; 62 FR 54759, Oct. 22, 1997; that no viable Salmonella organisms re- 64 FR 72175, Dec. 23, 1999; 65 FR 34390, May 30, main in the finished product, as well as 2000; 78 FR 66838, Nov. 7, 2013] the reduction of other pathogens and their toxins or toxic metabolites nec- § 381.146 Sampling at official establish- essary to prevent adulteration, must be ments. demonstrated to be achieved through- Inspectors may take, without cost to out the product. The lethality process the Department, such samples as are must include a cooking step. Con- necessary of any poultry product, or trolled intermediate step(s) applied to other article for use as an ingredient of raw product may form part of the basis any poultry product, at any official es- for the equivalency. tablishment to determine whether it (2) Stabilization. There can be no mul- complies with the requirements of the tiplication of toxigenic microorga- regulations. nisms such as Clostridium botulinum, and no more than a 1 log multiplica- § 381.148 Processing and handling re- 10 quirements for frozen poultry prod- tion of Clostridium perfringens within ucts. the product. (b) Partially cooked poultry break- Procedures with respect to processing of frozen ready-to-heat-and-eat fast strips must be produced using poultry products or stuffed ready-to- processes ensuring that the products roast poultry shall be in accordance meet the performance standard listed with sound operating practices and car- in paragraph (a)(2) of this section. La- ried out in a manner which will assure beling for these products must comply freedom from adulteration of the prod- with § 381.125. In addition, the state- ucts. Products to be frozen shall be ment ‘‘Partially Cooked: For Safety, moved into the freezer promptly under Cook Until Well Done’’ must appear on such supervision by an inspector as is the principal display panel in letters no necessary to assure preservation of the smaller than 1⁄2 the size of the largest products by prompt and efficient freez- letter in the product name. Detailed ing. Adequate freezing facilities shall cooking instructions shall be provided be provided within the official estab- on the immediate container of the lishment where products to be frozen products.

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(c) For each product produced using a of the rooms and equipment and rinsed process other than one conducted in ac- with potable water before use. cordance with the Hazard Analysis and (c) Hermetically sealed containers of Critical Control Point (HACCP) system poultry product which have been con- requirements in part 417 of this chap- taminated by polluted water shall be ter, an establishment must develop and examined promptly by the official es- have on file, available to FSIS, a proc- tablishment under supervision of an in- ess schedule, as defined in § 381.1(b). spector and rehandled as follows: Each process schedule must be ap- (1) Separate and condemn all poultry proved in writing by a process author- products in damaged or extensively ity for safety and efficacy in meeting rusted containers. the performance standards established (2) Remove paper labels and wash the for the product in question. A process remaining containers in warm soapy authority must have access to an es- water, using a brush where necessary tablishment in order to evaluate and to remove rust or other foreign mate- approve the safety and efficacy of each rial. Disinfect these containers by ei- process schedule. ther of the following methods: (d) Under the auspices of a processing (i) Immerse in a solution of sodium authority, an establishment must vali- hypochlorite containing not less than date new or altered process schedules 100 p/m of available chlorine or other by scientifically supportable means, equivalent disinfectant approved by such as information gleaned from the the Administrator, 1 rinse in potable literature or by challenge studies con- water, and dry thoroughly; or ducted outside the plant. (ii) Immerse in 212 °F. water, bring temperature of the water back to 212 [64 FR 746, Jan. 6, 1999] °F. and maintain the temperature at 212 °F. for 5 minutes, then remove con- § 381.151 Adulteration of product by polluted water; procedure for han- tainers from water and cool them to 95 dling. °F. and dry thoroughly. (3) After handling as described in (a) In the event there is polluted paragraph (c)(2) of this section, the water (including but not limited to containers may be relacquered, if nec- flood water) in an official establish- essary, and then relabeled with ap- ment, all poultry products and ingredi- proved labels applicable to the product ents for use in the preparation of such therein. products that have been rendered adul- (4) The identity of the canned poultry terated by the water shall be con- product shall be maintained through- demned. out all stages of the rehandling oper- (b) After the polluted water has re- ations, to insure correct labeling of ceded from an official establishment, containers. all walls, ceilings, posts, and floors of the rooms and compartments involved, [38 FR 34456, Dec. 14, 1973] including the equipment therein, shall, under the supervision of an inspector, § 381.152 Preparation in an official establishment of articles not for be cleaned thoroughly by the official human food. establishment personnel. An adequate supply of hot water under pressure is (a) Requirements applicable when pre- essential to make such cleaning effec- pared in an edible products department. tive. After cleaning a solution of so- When an article (including, but not dium hypochlorite containing approxi- being limited to, animal food) that is mately one-half of 1 percent available not for use as human food is prepared chlorine (5,000 p/m) or other equivalent in any room or compartment, in an of- disinfectant approved by the Adminis- ficial establishment where poultry trator 1 shall be applied to the surface products are prepared or handled (such room or compartment being herein referred to as an ‘‘edible products depart- 1 A list of approved disinfectants is available upon request to Scientific Services, ment’’), sufficient space and equipment Meat and Poultry Inspection Program, Food shall be provided to assure that the Safety and Inspection Service, U.S. Depart- preparation of the article in no way ment of Agriculture, Washington, DC 20250. interferes with the preparation or

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other handling of the poultry products. shall be allotted and adequate equip- Where necessary, separate equipment ment and facilities provided so that the shall be provided for the preparation of preparation of the article does not the article. To assure the maintenance interfere with the preparation of poul- of the requisite sanitary conditions in try products or the maintenance of the the edible products department, the op- requisite sanitary conditions in the of- erations incident to the preparation of ficial establishment. The preparation the article shall be subject to the same of any such article shall be subject to sanitary requirements as apply to the supervision by an inspector. handling of poultry products in the edi- (c) Containers to be labeled. The imme- ble products department. Preparation diate container of any such article that of the article shall be limited to those is prepared in an official establishment hours during which the official estab- shall be conspicuously labeled so as to lishment operates under the super- distinguish it from human food. Such vision of an inspector. The ingredients articles are also subject to the require- used in the preparation of the article ments under the Federal Food, Drug, shall, unless otherwise approved by the and Cosmetic Act. Administrator in specific cases, be such as may be used in the preparation of a § 381.153 [Reserved] poultry product. The article may be stored in, and distributed from, the edi- Subpart P—Definitions and Stand- ble products department if the article ards of Identity or Composi- is properly identified. tion (b) Requirements applicable when prepared in an inedible products department. § 381.155 General. When an article (including, but not (a) Authorization to establish specifica- being limited to, animal food) that is tions. (1) The Administrator is author- not for use as human food, is prepared ized to establish specifications or defi- in any part of an official establishment nitions and standards of identity or other than an edible products depart- composition, covering the principal ment (such part of the establishment constituents of any poultry product being herein referred to as the ‘‘ined- with respect to which a specified name ible products department’’), the area in of the product or other labeling termi- which such article is prepared shall be nology may be used, whenever he de- distinctly separated from all edible termines such action is necessary to products departments. Poultry prod- prevent sale of the product under false ucts and inedible products may be or misleading labeling. Further, the brought from any edible products de- Administrator is authorized to pre- partment into any inedible products scribe definitions and standards of department, but no poultry product or identity or composition for poultry inedible product may be brought from products whenever he determines such an inedible products department into action is otherwise necessary for the an edible products department except protection of the public. The require- that any such articles as are in sealed ments of this subpart are hereby found containers or are handled under condi- to be necessary for these purposes and tions prescribed or approved by the Ad- standards are hereby established as set ministrator in specific cases may be forth in this subpart. brought into an edible products depart- (2) Where cooked poultry meat is ment. Diseased carcasses or diseased specified in this subpart as an ingre- parts of any carcass shall not be used dient of poultry products, this means in the preparation of any animal food poultry meat derived from poultry unless they have been treated in the processed, cooked, and cooled in a man- manner prescribed in § 381.95(a). Trucks ner approved by the Administrator in or containers used for the transpor- specific cases without use of liquid or tation of poultry products or inedible moisture in direct contact with the products into an inedible products de- poultry meat following the cooking partment shall be cleaned before being and cooling of the poultry. returned to or brought into an edible (3) If, following cooking and cooling products department. Sufficient space of poultry meat to be used in poultry

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products, liquid or moisture is used in beled ‘‘Boned (Kind)—Solid Pack,’’ but direct contact with such poultry meat may be added in quantities not in ex- and the percentage of solids, excluding cess of a total of 0.5 percent of the salt, in the poultry meat is found to be total ingredients in the preparation of below 34 percent when such poultry other canned boned poultry products meat is tested by acceptable methods, and in such cases the common name of the percentage of poultry meat re- the substance shall be included in the quired by this section for any poultry name of the product, e.g., ‘‘Boned product shall be increased in propor- Chicken with Broth—Gelatin Added.’’ tion to the deficiency, or the meat (b) Canned boned poultry, except shall be so processed as to raise the sol- poultry within paragraph (c) of this ids content, excluding salt, to 34 per- section, shall meet the requirements cent. The official establishment shall set forth in Table II. The percentages furnish adequate facilities for such in Table II shall be calculated on the testing. basis of the total ingredients used in (b) Any binder or antimicrobial agent the preparation of the product. that has been found to be safe and suit- (c) Canned boned poultry with nat- able by the Food and Drug Administra- ural juices (Boned (Kind) with natural tion and the Food Safety and Inspec- juices) shall be prepared from either tion Service may be used in the produc- raw boned poultry or a mixture of raw tion of poultry products with standards boned poultry and cooked boned poul- of identity in this part, where the prod- try and shall have no liquid added dur- uct standards and applicable Federal ing the preparation of the product. regulations already permit the use of (d) Canned shredded poultry (Shred- these types of ingredients. ded Kind), consists of poultry meat re- [37 FR 9706, May 16, 1972, as amended at 68 duced to a shredded appearance, from FR 22578, Apr. 29, 2003] the kind of poultry indicated, with meat, skin, and fat not in excess of the § 381.156 Poultry meat content stand- natural whole carcass proportions. ards for certain poultry products. Canned shredded poultry from specific Poultry products with labeling ter- parts may include skin or fat in excess minology as set forth in Table I shall of the proportions normally found on a comply with the specifications for per- whole carcass, but not in excess of the cent light meat and percent dark meat proportions of skin and fat normal to set forth in said table. the particular part or parts; and such product shall be labeled in accordance TABLE I with § 381.117(d). Percent light Percent dark (e) Canned boned poultry shall be Label terminology meat meat prepared as set forth in Table II, items 1, 2, 3, or 4, whichever is applicable. Natural proportions ...... 50–65 ...... 50–35. Light or white meat ...... 100 ...... 0. Dark meat ...... 0 ...... 100. TABLE II Light and dark meat ..... 51–65 ...... 49–35. Dark and light meat ..... 35–49 ...... 65–51. Minimum Mostly white meat ...... 66 or more ...... 34 or less. percent Mostly dark meat ...... 34 or less ...... 66 or more. cooked, deboned Maximum poultry meat percent liq- Product name of kind indi- uid that [37 FR 9706, May 16, 1972, as amended at 39 may be cated, with 1 FR 4569, Feb. 5, 1974] skin, fat, added and seasoning § 381.157 Canned boned poultry and baby or geriatric food. 1. Boned (Kind)—solid pack ...... 95 5 2. Boned (Kind) ...... 90 10 (a) Canned boned poultry shall, un- 3. Boned (Kind) with broth 2 ...... 80 20 less otherwise specified in this section, 4. Boned (Kind) (ll) percent be prepared from cooked deboned poul- broth 23 ...... 50 50 try meat and may contain skin and fat 1 Liquid may be in the form of, but is not limited to, broth or not in excess of natural whole carcass extractives. 2 Alternatively, product may be prepared from raw boned proportions. Gelatin, stabilizers, or poultry in combination with cooked boned poultry so long as similar solidifying or emulsifying the product complies with the specified standard. 3 Total amount of liquid added shall be included in the name agents shall not be added to product la- of the product; e.g., ‘‘Boned Chicken with 25 percent broth.’’

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(f) Poultry products intended for in- I, Subchapter A or Subchapter B. In ad- fant or geriatric use and represented as dition to the binders referred to in the having a ‘‘high meat’’ content shall preceding sentence, the following sub- contain not less than 18.75 percent stances are permitted for use as bind- cooked, deboned poultry meat of the ers in poultry rolls: transglutaminase kind indicated, with seasoning. enzyme at up to 65 ppm. When binding agents are added in excess of 3 percent TABLE IIA for cooked rolls and 2 percent for raw Minimum rolls, the common name of the agent or percent cooked, Maximum the term ‘‘Binders Added’’ shall be in- deboned, percent liq- cluded in the name of the product; e.g., Product name poultry meat uid that may be ‘‘Turkey Roll-Gelatin Added.’’ of kind indi- 1 cated, with added (b) With respect to heat processed seasoning rolls, 2 percent or less liquid based on 1. Strained or chopped (Kind) the weight of the finished product with broth 23 ...... 43 57 without liquid may remain with or be 2. High meat dinner 3 ...... 18.75 returned to product labeled as ‘‘(Kind) 1 Liquid may be in the form of, but not limited to, broth or extractives. Roll.’’ 2 Alternatively, product may be prepared from raw boned (c) Heat processed rolls which have poultry meat in combination with cooked bone poultry meat so long as the product complies with the specified standard. more than 2 percent liquid remaining 3 Label must indicate in some manner that product is for in- with or returned to the product shall fant or geriatric servings. be labeled as ‘‘(Kind) Roll with Natural [37 FR 9706, May 16, 1972, as amended at 39 Juices.’’ If more than 2 percent of any FR 4569, Feb. 5, 1974] liquid other than natural cookout juices is added, the product must be la- § 381.158 Poultry dinners (frozen) and beled to indicate that fact; e.g., ‘‘Tur- pies. key Roll with Broth.’’ Liquid shall not Poultry dinners (frozen) and pies be returned or added to product within shall meet the requirements set forth this paragraph graph in excess of the in Table III of this section and the per- amount normally cooked out during centage or weight specified therein preparation. shall be calculated on the basis of total ingredients used in the preparation of [37 FR 9706, May 16, 1972, as amended at 55 the poultry product. FR 34684, Aug. 24, 1990; 66 FR 54916, Oct. 31, 2001] TABLE III § 381.160 (Kind) burgers; (Kind) pat- Minimum cooked Minimum raw ties. deboned poultry deboned poultry meat of kind indi- meat of kind indi- Such product consists of 100 percent cated cated poultry of the kind indicated, with Per- Per- skin and fat not in excess of natural cent Weight cent Weight proportions. Product containing fillers (Kind) Pies ...... 14 or 11⁄8 oz. 25 or 2 oz. or binders shall be named ‘‘(Kind) Pat- per 8-oz. per 8-oz. pie 1 pie. 1 ties.’’ (Kind) Dinners ...... 18 or 2 oz. 23 § 381.161 ‘‘(Kind) A La Kiev.’’ 1 14 percent or 11⁄8 oz., whichever is greater; or 25 percent or 2 oz., whichever is greater. Such product consists of poultry 2 Excluding weight of appetizers, desserts, etc. 3 18 percent or 2 oz., whichever is greater. A minimum of meat of the kind indicated, stuffed 45 percent, or 5 ounces per dinner, whichever is greater, of cooked poultry including bone and breading may be used in with butter which may be seasoned and lieu of minimum 18 percent or 2 ounces of cooked deboned the product may be wrapped in suffi- poultry meat and the cooked poultry including bone and breading shall not contain more than 30 percent breading. cient skin to cover the meat. It may be dipped in batter, fried, and frozen. § 381.159 Poultry rolls. (a) Binders or extenders may be § 381.162 ‘‘(Kind) steak or fillet.’’ added in accordance with a regulation Such product consists of a boneless in this subchapter, in 9 CFR Chapter slice or strip of poultry meat of the III, Subchapter E, or in 21 CFR Chapter kind indicated.

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§ 381.163 ‘‘(Kind) baked’’ or ‘‘(Kind) TABLE IV—Continued roasted.’’ Minimum Minimum Such product consists of ready-to- percent percent cooked cooked cook poultry of the kind indicated, Product name 1 deboned poultry of that has been cooked in dry source poultry meat kind indi- of kind indicated, indi- heat, e.g., oven roasted or oven baked. cated cating bone

§ 381.164 ‘‘(Kind) barbecued.’’ (Kind) Noodles or Dumplings 2 .. 15 30 (Kind) with Vegetables ...... 15 ...... Such product consists of ready-to- Gravy with sliced (Kind) ...... 15 ...... cook poultry of the kind indicated, (Kind) Tetrazzini ...... 15 ...... that has been cooked in dry heat and (Kind) chili with beans ...... 17 ...... Creamed (Kind) ...... 20 ...... basted with a seasoned sauce. (Kind) Cacciatore ...... 20 40 (Kind) Fricassee ...... 20 40 § 381.165 ‘‘(Kind) barbecued prepared (Kind) A-La-King ...... 20 ...... with moist heat.’’ (Kind) croquettes ...... 25 ...... Slice (Kind) with Gravy and Such product consists of ready-to- Dressing ...... 25 ...... cook poultry of the kind indicated that (Kind) Salad 3 ...... 25 ...... has been cooked by the action of moist (Kind) chili ...... 28 ...... (Kind) Hash ...... 30 ...... heat in a barbecue sauce. Sliced (Kind) with Gravy ...... 35 ...... Minced (Kind) Barbecue ...... 40 ...... § 381.166 Breaded products. 1 The product name may contain other appropriate descrip- ‘‘Breaded’’ is a term applicable to tive terms such as ‘‘noodle’’; e.g., ‘‘Chicken Noodle Soup.’’ 2 This standard also applies to products named (Kind) with any poultry product which is coated rice or similar starches. with breading or a batter and breading 3 The 25 percent-standard listed includes poultry meat plus proportions of skin and fat natural to the poultry used. in an amount not to exceed 30 percent of the weight of the finished breaded [37 FR 9706, May 16, 1972, as amended at 39 product. FR 4569, Feb. 5, 1974]

§ 381.167 Other poultry dishes and spe- § 381.168 Maximum percent of skin in cialty items. certain poultry products. Poultry dishes and specialty items The poultry products listed in Table listed in Table IV of this paragraph V shall have not more than the percent shall meet the requirements set forth of skin specified in the table, when raw in said table, irrespective of the type of and when cooked. packaging, and the percentages in Table IV shall be calculated on a TABLE V ready-to-serve basis, except that soup Percent skin bases in institutional packs which are Product name prepared for sale to institutional users Raw Cooked shall have a minimum of 15 percent Boneless Turkey Breast cooked deboned poultry meat based on or the weight of the soup base product. Boneless Turkey Breast Roll ...... 14 Boneless Turkey Thigh or TABLE IV Boneless Turkey Thigh Roll ...... 8 Boneless Turkey Minimum Minimum or percent percent cooked cooked Turkey Roll ...... 15 Product name 1 deboned poultry of Boneless Chicken Breast poultry meat kind indi- or of kind indicated, indi- Boneless Chicken Breast Roll ...... 18 20 cated cating bone Boneless Chicken or (Kind) Ravioli ...... 2 ...... Chicken Roll ...... 20 25 (Kind) Soup ...... 2 ...... Chop Suey with (Kind) ...... 2 ...... (Kind) Chop Suey ...... 4 ...... § 381.169 Ready-to-cook poultry prod- (Kind) Chow Mein without noo- ucts to which solutions are added. dles ...... 4 ...... (Kind) Tamales ...... 6 ...... (a) Butter alone, or solutions of poul- Noodles or Dumplings with try broth, poultry stock, water, or edi- (Kind) 2 ...... 6 ...... (Kind) Stew ...... 12 ...... ble fats, or mixtures thereof, in which (Kind) Fricassee of Wings ...... 40 are included functional substances

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such as spices, flavor enhancers, emul- turkey and proportionately smaller for sifiers, phosphates, coloring materials, other poultry products. The remainder or other substances, approved by the of the solution ingredients shall be de- Administrator in specific cases, may be clared in type at least one-eighth inch introduced by injection into the thick in height. The entire statement must muscles (breast and legs) of ready-to- be printed in a color that contrasts cook poultry carcasses and may be in- with the background and be displayed troduced by injection or marinating on the principal display panel. into any separate bone-in part there- (c) Approval for use of a label for from, for the purpose of providing a product under this section depends basting medium or similar function. upon the ability of the processor to The ingredients of the added materials control the finished product, within a and the manner of addition to the prod- range of three-tenths of 1 percent accu- ucts must be found acceptable by the racy, so that the average percent of Administrator, in all cases. The intro- basting material in each outgoing lot duction of the added materials shall in- is not greater than 3.3 percent or less crease the weight of the processed than 2.7 percent of basting material product by approximately 3 percent when tested by an approved plant con- over the weight of the raw product trol procedure would be in compliance. after washing and chilling in compli- As used in this section, ‘‘a lot’’ may be ance with § 381.66. The weight of the any reasonable portion of production added materials introduced into the designated by the operator of the offi- poultry products as provided in this cial establishment, with a maximum of paragraph shall be included as part of an entire shift’s production from one the weight of the poultry for purposes production line. The control procedures of the net weight labeling provisions in to be eligible for approval by the Ad- § 381.121(b). ministrator must: (b) A raw poultry product, into which (1) Assure compliance with all label- added materials are introduced as pro- ing requirements. vided in paragraph (a) of this section (2) Control the variability of the must be labeled with a conspicuous, amount of added approved solution legible, and descriptive name, includ- within the limits defined above. ing terms that concisely describe the (3) Provide for the disposition in ac- method of addition and function of the cordance with the regulations of all added material. All major terms in the products not in compliance with this product name must be printed with the section. same prominence, except that the (4) Incorporate a system of raw words which describe the function of weight identification of a sufficient the added materials (such as ‘‘Injected number of poultry and/or poultry parts for Flavored Basting’’) may be more to allow effective monitoring of the prominent, provided this does not de- system by Federal inspectors and offi- tract from the conspicuousness of the cial establishment employees. other terms in the product name (such [37 FR 9706, May 16, 1972, as amended at 39 as ‘‘Young Turkey’’). The label must FR 36000, Oct. 7, 1974] also bear a statement, in bold type, im- EFFECTIVE DATE NOTE: At 79 FR 79062, Dec. mediately below and adjacent to the 31, 2014, § 381.169 was removed and reserved, product name, listing the common or effective Jan. 1, 2016. usual names of the added materials in descending order of predominance. The § 381.170 Standards for kinds and first part of this statement must con- classes, and for cuts of raw poultry. sist of terms adequate to inform con- (a) The following standards specify sumers about the amount and manner the various classes of the specified of introduction of the solution (such as kinds of poultry and the requirements ‘‘Injected with approximately 3 percent for each class: of a solution of lllll’’), and must (1) Chickens—(i) Rock Cornish game be printed at least one-fourth the size hen or Cornish game hen. A ‘‘Rock Cor- of the most prominent letter in the nish game hen’’ or ‘‘Cornish game hen’’ product name, with a minimum size of is a young, immature chicken (less one-fourth inch for a ready-to-cook than 5 weeks of age), of either sex, with

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a ready-to-cook carcass weight of not and toughened flesh. Sex designation is more than 2 pounds. optional. (ii) Broiler or fryer. A ‘‘broiler’’ or (3) Ducks—(i) Duckling. A ‘‘duckling’’ ‘‘fryer’’ is a young chicken (less than 10 is a young duck (less than 8 weeks of weeks of age), of either sex, that is ten- age), of either sex, that is tender- der-meated with soft, pliable, smooth- meated and has a soft bill and soft textured skin and flexible breastbone windpipe. cartilage. (ii) Roaster duck. A ‘‘roaster duck’’ is (iii) Roaster or roasting chicken. A a young duck (less than 16 weeks of ‘‘roaster’’ or ‘‘roasting chicken’’ is a age), of either sex, that is tender- young chicken (between 8 and 12 weeks meated and has a bill that is not com- of age), of either sex, with a ready-to- pletely hardened and a windpipe that is cook carcass weight of 5 pounds or easily dented. more, that is tender-meated with soft, (iii) Mature duck or old duck. A ‘‘ma- pliable, smooth-textured skin and ture duck’’ or an ‘‘old duck’’ is an breastbone cartilage that is somewhat adult duck (more than 6 months of less flexible than that of a broiler or age), of either sex, with toughened fryer. flesh, a hardened bill, and a hardened (iv) Capon. A ‘‘capon’’ is a surgically windpipe. neutered male chicken (less than 4 (4) Geese—(i) Young goose. A ‘‘young goose’’ is an immature goose, of either months of age) that is tender-meated sex, that is tender-meated and has a with soft, pliable, smooth-textured windpipe that is easily dented. skin. (ii) Mature goose or old goose. A ‘‘ma- (v) Hen, fowl, baking chicken, or stew- ture goose’’ or ‘‘old goose’’ is an adult A ‘‘hen,’’ ‘‘fowl,’’ ‘‘baking ing chicken. goose, of either sex, that has toughened chicken,’’ or ‘‘stewing chicken’’ is an flesh and a hardened windpipe. adult female chicken (more than 10 (5) Guineas—(i) Young guinea. A months of age) with meat less tender ‘‘young guinea’’ is an immature guin- than that of a roaster or roasting ea, of either sex, that is tender-meated chicken and a nonflexible breastbone and has a flexible breastbone cartilage. tip. (ii) Mature guinea or old guinea. A (vi) Cock or rooster. A ‘‘cock’’ or ‘‘mature guinea’’ or ‘‘old guinea’’ is an ‘‘rooster’’ is an adult male chicken adult guinea, of either sex, that has with coarse skin, toughened and dark- toughened flesh and a non-flexible ened meat, and a nonflexible breast- breastbone. bone tip. (b) The following standards specify (2) Turkeys—(i) Fryer-roaster turkey. A the requirements for the specified cuts ‘‘fryer-roaster turkey’’ is an immature of poultry: turkey (less than 12 weeks of age), of (1) ‘‘Breasts’’ shall be separated from either sex, that is tender-meated with the back at the shoulder joint and by a soft, pliable, smooth-textured skin, and cut running backward and downward flexible breastbone cartilage. from that point along the junction of (ii) Young turkey. A ‘‘young turkey’’ the vertebral and sternal ribs. The ribs is a turkey (less than 8 months of age), may be removed from the breasts, and of either sex, that is tender-meated the breasts may be cut along the with soft, pliable, smooth-textured breastbone to make two approximately skin and breastbone cartilage that is equal halves; or the wishbone portion, less flexible than that of a fryer-roast- as described in paragraph (b)(3) of this er turkey. section, may be removed before cutting (iii) Yearling turkey. A ‘‘yearling tur- the remainder along the breastbone to key’’ is a turkey (less than 15 months make three parts. Pieces cut in this of age), of either sex, that is reasonably manner may be substituted for lighter tender-meated with reasonably or heavier pieces for exact weight-mak- smooth-textured skin. ing purposes and the package may con- (iv) Mature or old (hen or tom) turkey. tain two or more of such parts without A ‘‘mature turkey’’ or ‘‘old turkey’’ is affecting the appropriateness of the la- an adult turkey (more than 15 months beling as e.g., ‘‘chicken breasts.’’ Neck of age), of either sex, with coarse skin skin shall not be included with the

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breasts, except that ‘‘turkey breasts’’ the appropriateness of the name. Skin may include neck skin up to the whisk- shall be substantially intact. er. (9) ‘‘Stripped backs’’ shall include the (2) ‘‘Breasts with ribs’’ shall be sepa- vertebrae from the shoulder joint to rated from the back at the junction of the tail, and include the pelvic bones. the vertebral ribs and back. Breasts The meat may be stripped off of the with ribs may be cut along the breast- pelvic bones. bone to make two approximately equal (10) ‘‘Necks’’, with or without neck halves; or the wishbone portion, as de- skin, shall be separated from the car- scribed in paragraph (b)(3) of this sec- cass at the shoulder joint. tion, may be removed before cutting (11) ‘‘Halves’’ are prepared by making the remainder along the breastbone to a full-length back and breast split of an make three parts. Pieces cut in this eviscerated poultry carcass so as to manner may be substituted for lighter produce approximately equal right and or heavier pieces for exact weight-mak- left sides. ing purposes and the package may con- (12) ‘‘Quarters’’ consist of the entire tain two or more of such parts without eviscerated poultry carcass, which has affecting the appropriateness of the la- been cut into four equal parts, but ex- beling as ‘‘breasts with ribs.’’ Neck cluding the neck. skin shall not be included, except that (13) ‘‘Breast quarter’’ consists of half ‘‘turkey breasts with ribs’’ may include a breast with the wing and a portion of neck skin up to the whisker. the back attached. (3) ‘‘Wishbones’’ (Pulley Bones), with (14) ‘‘Breast quarter without wing’’ covering muscle and skin tissue, shall consists of a front quarter of a poultry be severed from the breast approxi- carcass, from which the wing has been mately halfway between the end of the removed. wishbone (hypocledium) and front (15) ‘‘Leg quarter’’ consists of a poul- point of the breastbone (cranial process try thigh and drumstick, with a por- of the sternal crest) to a point where tion of the back attached. the wishbone joins the shoulder. Neck (16) ‘‘Thigh with back portion’’ con- skin shall not be included with the sists of a poultry thigh with back por- wishbone. tion attached. (4) ‘‘Drumsticks’’ shall be separated (17) ‘‘Legs with pelvic bone’’ consists from the thigh by a cut through the of a poultry leg with adhering meat knee joint (femorotibial and patellar and skin and pelvic bone. joint) and from the hock joint (tarsal (18) ‘‘Wing drummette’’ consists of joint). the humerus of a poultry wing with ad- (5) ‘‘Thighs’’ shall be disjointed at hering skin and meat attached. the hip joint and may include the pel- (19) ‘‘Wing portion’’ consists of a vic meat, but shall not include the pelvic bones. Back skin shall not be in- poultry wing except that the cluded. drummette has been removed. (6) ‘‘(Kind) legs’’ shall be the poultry (20) ‘‘Cut-up Poultry’’ is any cut-up product which includes the thigh and or disjointed portion of poultry or any the drumstick, i.e., the whole leg, and edible part thereof, as described in this may include the pelvic meat, but shall section. not include the pelvic bones. Back skin (21) ‘‘Giblets’’ consist of approxi- shall not be included. mately equal numbers of hearts, giz- (7) ‘‘Wings’’ shall include the entire zards, and livers, as determined on a wing with all muscle and skin tissue count basis. intact, except that the wingtip may be (22) ‘‘Major portions’’ of eviscerated removed. poultry carcasses are either carcasses (8) ‘‘Backs’’ shall include the pelvic from which parts may be missing, or bones and all the vertebrae posterior to the front or rear portions of trans- the shoulder joint. The meat shall not versely-split carcasses. be peeled from the pelvic bones. The [37 FR 9706, May 16, 1972, as amended at 39 vertebral ribs and/or scapula may be FR 4569, Feb. 5, 1974; 63 FR 48960, Sept. 11, removed or included without affecting 1998; 76 FR 68064, Nov. 3, 2011]

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§ 381.171 Definition and standard for product is ‘‘Chunked and Formed.’’ The ‘‘Turkey Ham.’’ product name of product fabricated (a) ‘‘Turkey Ham’’ shall be fabricated from such pieces of turkey thigh meat from boneless, turkey thigh meat with smaller than the equivalent of a one- skin and the surface fat attached to half inch cube shall be further qualified the skin removed. The thighs shall be to specify that the product is ‘‘Ground that cut of poultry described in and Formed’’ or ‘‘Chopped and § 381.170(b)(5) of this part. Formed’’ as appropriate. The quali- (b) The product may or may not be fying statement shall immediately fol- smoked, and shall be cured using one low and be contiguous to the statement or more of the approved curing agents required in paragraph (e) of this sec- as provided in a regulation permitting tion, and shall be not less than one-half that use in this subchapter or 9 CFR the size of the product name but not Chapter III, Subchapter E, or in 21 CFR less than one-eighth inch in height, Chapter I, Subchapter A or Subchapter and shall be in the same style and color B. The product may also contain cure and with the same background as the accelerators, phosphates, and flavoring product name. agents as provided in a regulation per- [44 FR 51190, Aug. 31, 1979; 64 FR 72175, Dec. mitting that use in this subchapter or 23, 1999] 9 CFR Chapter III, Subchapter E, or in 21 CFR Chapter I, Subchapter A or § 381.172 Requirements for substitute Subchapter B; common salt, sugars, standardized poultry products spices, spice extractives, dehydrated named by use of an expressed nutri- garlic, and dehydrated onions; and ent content claim and a standard- water for purpose of dissolving and dis- ized term. persing the substances specified above. (a) Description. The poultry products (c) The cooked finished product prescribed by this general definition weight shall be no more than the origi- and standard of identity are those nal weight of the turkey thigh meat products that substitute, in accordance used prior to curing. with § 381.413(d), for a standardized (d) The product name on the label product defined in this subpart and use shall show the word ‘‘Turkey’’ in the the name of that standardized product same size, style, color, and with the in their statements of identity, but same background as the word ‘‘Ham’’ that do not comply with the estab- and shall precede and be adjacent to it. lished standard because of a (e) The product name shall be quali- compositional deviation that results fied with the statement ‘‘Cured Turkey from reduction of a constituent that is Thigh Meat.’’ The qualifying statement described by an expressed nutrient con- shall be contiguous to the product tent claim that has been defined by name, without intervening type or de- regulation in this subpart. The ex- signs, shall be not less than one-half pressed nutrient content claim shall the size of the product name but not comply with the requirements of less than one-eighth inch in height, § 381.413 and with the requirements in and shall be in the same style and color subpart Y of this part which define the and with the same background as the particular nutrient content claim that product name. is used. The poultry product shall com- (f) If the product is fabricated from ply with the relevant standard in this pieces of turkey thigh meat that result part in all other respects, except as from the cutting through the muscle provided in paragraphs (b) and (c) of (as opposed the whole thighs intact or this section. whole thighs with some incidental sep- (b) Performance characteristics. The aration of muscle tissue during re- performance characteristics, such as moval of the bone), the product name physical properties, functional prop- shall be further qualified by a descrip- erties, and shelf-life, of the poultry tive statement. The product name of product shall be similar to those of the product fabricated from such pieces of standardized poultry product produced turkey thigh meat equivalent in size to under subpart P of this part. If there is a one-half inch cube or greater shall be a significant difference in a perform- further qualified to specify that the ance characteristic that materially

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limits the use of the product compared (d) Nomenclature. The name of a sub- to the use of the standardized product stitute poultry product that complies defined in subpart P of this part, the with this section is the appropriate ex- label shall include a statement in ac- pressed nutrient content claim and the cordance with § 381.413(d)(1) and (2) of applicable standardized term. this part, that informs the consumer of (e) Label declaration. (1) Each of the such differences (e.g., if appropriate, ingredients used in the substitute poul- ‘‘not recommended for frozen storage’’ try product shall be declared on the or ‘‘not suitable for roller grilling’’). label as required by this section and Deviations from the ingredient provi- subpart N of this part. sions of the standard must be the min- (2) Ingredients not provided for, and imum necessary to qualify for the nu- ingredients used in excess of those lev- trient content claim, while maintain- els provided for, by the standard as de- ing similar performance characteris- fined in subpart P of this part, shall be tics. identified as such with an asterisk in (c) Ingredients used in substitute prod- the ingredients statement. The state- ucts. (1) Ingredients used in the product ment ‘‘*Ingredients not in regular shall be those ingredients provided for lllll’’ (the blank shall be filled in in the standard as defined in subpart P with the name of the traditional stand- of this part, except that safe and suit- ardized product) or ‘‘**Ingredients in able ingredients permitted for use in excess of amounts permitted in regular poultry products as provided in a regu- lllll’’ (the blank shall be filled in lation permitting that use in this sub- with the name of the traditional stand- chapter or in 9 CFR Chapter III, Sub- ardized product), or both, as appro- chapter E, or in 21 CFR Chapter I, Sub- priate, shall immediately follow the in- chapter A or Subchapter B, may be gredients statement in the same type used at the minimum level necessary and size. to improve texture and prevent syn- [70 FR 33818, June 10, 2005] eresis, so that the substitute product is not inferior in performance character- § 381.173 Mechanically Separated istics from the standardized product (Kind of Poultry). defined in subpart P of this part for (a) ‘‘Mechanically Separated (Kind of which it is a substitute. Poultry)’’ is any product resulting (2) An ingredient that is specifically from the mechanical separation and re- required by the standard prescribed in moval of most of the bone from at- subpart P of this part shall not be re- tached skeletal muscle and other tissue placed or exchanged with a similar in- of poultry carcasses and parts of car- gredient from another source, for ex- casses that has a paste-like form and ample, extruded turnips shall not re- consistency, that may or may not con- place noodles in poultry with noodles. tain skin with attached fat and meet- (3) An ingredient that is specifically ing the other provisions of this section. prohibited from use in any poultry Examples of such product are ‘‘Me- product by subpart P of this part shall chanically Separated Chicken’’ and not be added to the substitute poultry ‘‘Mechanically Separated Turkey.’’ product under this section. (b) ‘‘Mechanically Separated (Kind of (4) Unless otherwise specified in this Poultry)’’ shall not have a bone solids part, a substitute poultry product must content of more than 1 percent. At meet all other requirements of the ap- least 98 percent of the bone particles plicable standards of identity or com- present in ‘‘Mechanically Separated position. (Kind of Poultry) ‘‘ shall have a max- (5) Water and fat-replacers (e.g., bind- imum size no greater than 1.5 mm (mil- ers), in combination, may be added to limeter) in their greatest dimension replace fat in accordance with para- and there shall be no bone particles graph (c) of this section. larger than 2.0 mm in their greatest di- (6) Textured vegetable protein may mension. be used by itself or in combination (c) ‘‘Mechanically Separated (Kind of with other binders and water as a fat Poultry)’’ shall not have a calcium replacer in accordance with paragraph content exceeding 0.235 percent when (c) of this section. made from mature chickens or from

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turkeys as defined in § 381.170(a)(l)(vi) (1) Any person that engages in the and (vii) and (a)(2), respectively, or business of slaughtering any poultry or 0.175 percent when made from other processing, freezing, packaging, or la- poultry, based on the weight of product beling any carcasses, or parts or prod- that has not been heat treated, as a ucts of carcasses, of any poultry, for measure of a bone solids content of not commerce, for use as human food or more than 1 percent. animal food; (d) ‘‘Mechanically Separated (Kind of (2) Any person that engages in the Poultry)’’ may be used in the formula- business of buying or selling (as a poul- tion of poultry products in accordance try products broker, wholesaler, or with § 381.174 and meat food products in otherwise) or transporting, in com- accordance with subchapter A of this merce, or storing in or for commerce, chapter. or importing, any carcasses, or parts or (e) Product resulting from the me- products of carcasses, of any poultry; chanical separation process that fails (3) Any person that engages in busi- to meet the bone particle size or cal- ness, in or for commerce, as a renderer, cium content requirements for ‘‘Me- or engages in the business of buying, chanically Separated (Kind of Poul- selling, or transporting in commerce, try)’’ shall be used only in producing or importing, any dead, dying, dis- poultry extractives, including fats, abled, or diseased poultry or parts of stocks, and broths and labeled as ‘‘Me- the carcasses of any poultry that died chanically Separated (Kind of Poultry) otherwise than by slaughter. for Further Processing.’’ (b) The required records are: [60 FR 55983, Nov. 3, 1995] (1) Records, such as bills of sale, invoices, bills of lading, and receiving § 381.174 Limitations with respect to and shipping papers, giving the fol- use of Mechanically Separated lowing information with respect to (Kind of Poultry). each transaction in which any poultry (a) A poultry product required to be or poultry carcass, or part or product prepared from a particular kind of of a poultry carcass, is purchased, sold, poultry (e.g., chicken) shall not con- shipped, received, transported, or oth- tain ‘‘Mechanically Separated (Kind of erwise handled by said person in con- Poultry)’’ described in § 381.173, that is nection with any business subject to made from any other kind of poultry the Act. (e.g., Mechanically Separated Turkey). (i) The name or description of the (b) ‘‘Mechanically Separated (Kind of poultry or other articles; Poultry)’’ described in § 381.173 may be (ii) The net weight of the poultry or used in the formulation of any poultry other articles; or meat food product, provided such (iii) The number of outside con- use conforms with any applicable re- tainers; quirements of the definitions and (iv) The name and address of the standards of identity or composition in buyer of the poultry or other articles this subchapter or part 319 of this chap- sold by such person, and the name and ter, and provided that it is identified as address of the seller of the poultry or ‘‘Mechanically Separated (Kind of other articles purchased by such per- Poultry).’’ son; [60 FR 55983, Nov. 3, 1995] (v) The name and address of the consignee or receiver (if other than the Subpart Q—Records, Registration, buyer); and Reports (vi) The method of shipment; (vii) The date of shipment; and § 381.175 Records required to be kept. (viii) The name and address of the (a) Every person within any of the carrier. classes specified in paragraph (a) (1), (2) Guaranties provided by suppliers (2), or (3) of this section is required by of packaging materials under § 381.144. the Act to keep such records as are (3) Records of canning as required by properly necessary for the effective en- subpart X of this part 381, of sub- forcement of the Act: chapter C, 9 CFR chapter III.

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(4) Records of irradiation as required § 381.178 Access to and inspection of by sections 381.149 of this part. records, facilities and inventory; (5) Records of nutrition labeling as copying and sampling. required by subpart Y of this part. Representatives of the Secretary af- (6) Records of all labeling, along with forded access to a business specified in the product formula, processing proce- § 381.175 of this part (see § 300.6(b)(2) of dures, and any additional documenta- this chapter) also must be afforded any tion needed to support that the labels necessary facilities (other than repro- are consistent with the Federal meat duction equipment) for the examina- and poultry regulations and policies on tion and copying of records and the ex- labeling, as prescribed in § 412.1 of this amination and sampling of inventory. chapter. [69 FR 255, Jan. 5, 2004] (Approved by the Office of Management and Budget under control number 0583–0015) § 381.179 Registration. [37 FR 9706, May 16, 1972, as amended at 47 (a) Except as provided in paragraph FR 746, Jan. 7, 1982; 49 FR 2236, Jan. 19, 1984; (c) of this section, every person that 51 FR 45633, Dec. 19, 1986; 57 FR 43600, Sept. engages in business, in or for com- 21, 1992; 58 FR 675, Jan. 6, 1993; 60 FR 67458, merce, as a poultry products broker, Dec. 29, 1995; 78 FR 66838, Nov. 7, 2013] renderer, or animal food manufacturer, or engages in business in commerce as § 381.176 Place of maintenance of a wholesaler of any carcasses, or parts records. or products of the carcasses, of any Every person engaged in any business poultry, whether intended for human described in § 381.175(a) shall maintain food or other purposes, or engages in the records required by § 381.175 at the the business as a public warehouseman place of business where such business is storing any such articles in or for com- conducted, except that, if such person merce, or engages in the business of conducts such business at multiple lo- buying, selling, or transporting in com- cations, he may maintain such records merce, or importing, any dead, dying, at his headquarters’ office. When not in disabled, or diseased poultry, or parts actual use, all such records shall be of the carcasses of any poultry that kept in a safe place at the prescribed died otherwise than by slaughter, shall location in accordance with good com- register with the Administrator, giving mercial practices. such information as is required, including his name, and the address of each § 381.177 Record retention period. place of business at which, and all (a) Every record required to be main- trade names under which he conducts tained under this subpart shall be re- such business. Such persons shall reg- tained for a period not to exceed 2 ister under this section by filing with years after December 31 of the year in the Administrator, Food Safety and In- which the transaction to which the spection Service, U.S. Department of record relates has occurred, and for Agriculture, Washington, DC 20250, a form containing such information, such further period as the Adminis- within 90 days after the effective date trator may require for purposes of any hereof or after such later date as he be- investigation or litigation under the gins to engage in such business if not Act, by written notice to the person re- engaged therein upon said effective quired to keep such record under this date. All information submitted shall subpart. be current and correct. The registra- (b) Records of canning as required by tion form shall be obtained from Dis- subpart X of this part 381, subchapter trict Enforcement Operations, Field C, 9 CFR chapter III, shall be retained Operations, Food Safety and Inspection as required in § 381.307; except that Service, U.S. Department of Agri- records required by § 381.302 (b) and (c) culture, Washington, DC 20250 or by shall be retained as required by those calling the District Office. sections. (b) Whenever any change is made in [37 FR 9706, May 16, 1972, as amended at 51 the name of, or address of any place of FR 45633, Dec. 19, 1986] business at which, or any trade name

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under which a registrant conducts his ble of use as human food and is in fact business, he shall report such change in adulterated or misbranded at the time writing to the Administrator within 15 of such sale, transportation, offer, or days after making the change. receipt: Provided, That any such alleg- (c) The registration requirements edly adulterated or misbranded product prescribed in this section shall not may be transported to any official es- apply to persons conducting any of the tablishment for reinspection. businesses specified in this section only at an official establishment. § 381.182 Reports of inspection work. [37 FR 9706, May 16, 1972, as amended at 39 Reports of the inspection work car- FR 4569, Feb. 5, 1974; 57 FR 53982, Nov. 16, ried on within official establishments 1992; 69 FR 255, Jan. 5, 2004] shall be forwarded to the Adminis- trator by the inspector in charge in § 381.180 Information and reports re- such a manner as may be specified by quired from official establishment the Administrator. operators. (a) The operator of each official es- Subpart R—Cooperation With tablishment shall furnish to Program employees accurate information as to States and Territories; Certifi- all matters needed by them for making cation of State and Territorial their daily reports of the amount of Programs as at Least Equal to products prepared or handled in the de- Federal Program partments of the establishment to which they are assigned and such re- § 381.185 Assistance to State and Terri- ports concerning sanitation, manda- torial programs. tory microbiological testing, and other (a) The Administrator is authorized, aspects of the operations of the estab- under paragraph (a) of section 5 of the lishment and the conduct of inspection Act, when he determines it would effec- thereat, as may be required by the Ad- tuate the purposes of the Act, to co- ministrator in special cases. operate with any State (including (b) The operator of each official es- Puerto Rico) or any organized territory tablishment shall also make such other in developing and administering the reports as the Administrator may from poultry product inspection program of time to time require under the Act. such jurisdiction, with a view to assuring that it imposes and enforces re- [37 FR 9706, May 16, 1972, as amended at 61 FR 38868, July 25, 1996] quirements at least equal to those under sections 2 through 4, 6 through § 381.181 Reports by consignees of al- 10, and 12 through 22 of the Act, with legedly adulterated or misbranded respect to establishments at which products; sale or transportation as poultry are slaughtered or poultry violations. products are processed for use as Whenever the consignee of any poul- human food, solely for distribution try product which bears an official in- within such jurisdiction, and with re- spection legend refuses to accept deliv- spect to the poultry products of such ery of such product on the grounds that establishments. Such cooperation is it is adulterated or misbranded, the authorized if the jurisdiction has en- consignee shall notify the appropriate acted a mandatory law imposing ante program supervisor, Meat and Poultry mortem and post mortem inspection, Inspection Program, Food Safety and reinspection, and sanitation require- Inspection Service, U.S. Department of ments (at least equal to those under Agriculture, of the kind, quantity, the Federal Act), with respect to all or source and present location of the certain classes of persons engaged in product and the respects in which it is slaughtering poultry or otherwise proc- alleged to be adulterated or mis- essing poultry products for use as branded, and it will be a violation of human food solely for distribution the Act for any person to sell or trans- within such jurisdiction. port, or offer for sale or transportation (b) The Administrator is also author- or receive for transportation, in com- ized under paragraph (a) of section 5 of merce, any such product which is capa- the Act, to cooperate with any State

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(including Puerto Rico) or any orga- (b) Establishments selected to par- nized territory in developing and ad- ticipate in a cooperative interstate ministering programs under the laws of shipment program described in this such jurisdiction containing authori- section must receive inspection serv- ties at least equal to those provided in ices from designated State personnel section 11 of the Act (relating to that have been trained in the enforce- records; registration of specified class- ment of the Act. If the designated per- es of operators; dead, dying, disabled, sonnel determine that the poultry or diseased poultry; and products not products prepared in establishments se- intended for human food) when he de- lected to participate in the cooperative termines that such cooperation would interstate shipment program comply effectuate the purposes of the Act. with all requirements under the Act, (c) Such cooperation may include ad- these items will bear an official Fed- visory assistance, technical and labora- eral mark of inspection and may be tory assistance and training, and finan- shipped in interstate commerce. The cial aid. The Federal contribution to Administrator will assign an FSIS any State (or territory) for any year ‘‘selected establishment coordinator,’’ shall not exceed 50 percent of the esti- who will be an FSIS employee, to each mated total cost of the cooperative State that participates in a coopera- State (or territorial) program. A coop- tive interstate shipment program to erative program under this section is provide Federal oversight of the pro- called a State-Federal program. gram and enforcement of the program’s requirements. The Federal contribu- § 381.186 Cooperation of States and tion for inspection services provided by other jurisdictions in Federal pro- States that enter into a cooperative grams. interstate shipment program under Under the ‘‘Talmadge-Aiken Act’’ of this section will be at least 60 percent September 28, 1962 (7 U.S.C. 450), the of eligible State costs. Eligible State Administrator is authorized under costs are those costs that a State has stated conditions to utilize employees justified and FSIS has approved as nec- and facilities of any State in carrying essary for the State to provide inspec- out Federal functions under the Poul- tion services to selected establish- try Products Inspection Act. A cooper- ments in the State. ative program for this purpose is called (c) Subpart Z, of this part 381 pre- a Federal-State program. Under para- scribes conditions under which States graph (a) of section 5 of the Poultry and establishments may participate in Products Inspection Act, the Adminis- the cooperative interstate shipment trator is also authorized to conduct ex- program. aminations, investigations, and inspec- (d) The Administrator will terminate tions under the Act through any officer a cooperative interstate shipment or employee of any State or territory agreement with a State if the Adminis- or the District of Columbia commis- trator determines that the State is not sioned by him for such purpose. conducting inspection at selected establishments in a manner that com- § 381.187 Cooperation of States for the plies with the Act and the imple- interstate shipment of poultry prod- menting regulations in this chapter. ucts. (a) The Administrator is authorized [76 FR 24756, May 2, 2011] under 21 U.S.C. 472(b) to coordinate with States that have poultry products Subpart S—Transportation; Expor- inspection programs as provided in tation; or Sale of Poultry or § 381.185 of this subpart to select cer- Poultry Products tain establishments operating under these programs to participate in a co- § 381.189 Provisions inapplicable to operative program to ship poultry specimens for laboratory examina- products in interstate commerce. A co- tion, etc., or to naturally inedible operative program for this purpose is articles. called a ‘‘cooperative interstate ship- The provisions of this subpart do not ment program.’’ apply:

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(a) To dead, dying, disabled or dis- or from any official establishment, any eased poultry and specimens of slaughtered poultry from which the undenatured, uninspected or adulter- blood, feathers, feet, head, or viscera ated carcasses, parts, or products of have not been removed in accordance poultry sent to or by the Department with the regulations. of Agriculture or divisions thereof in (b)(1) No person shall sell, transport, Washington, DC, or elsewhere, for lab- offer for sale or transportation, or re- oratory examination, exhibition pur- ceive for transportation, in commerce, poses, or other official use; any slaughtered poultry or other poul- (b) To dead, dying, disabled or dis- try product which is capable of use as eased poultry and specimens of human food and is adulterated or fails undenatured, uninspected or adulter- to bear an official inspection legend or ated carcasses, parts, or products of is otherwise misbranded at the time of poultry thereof for educational, re- such sale, transportation, offer or research, or other nonfood purposes ceipt, except as otherwise provided in shipped under permit issued by the in- this paragraph (b) and subpart C or T. spector in charge upon his determina- (2)(i) Poultry heads and feet that are tion that collection and movement collected and handled at an official es- thereof will not interfere with inspec- tablishment in an acceptable manner tion or sanitary conditions at the es- may be shipped from the official estab- tablishment, and the specimens are for lishment directly for export as human nonfood purposes. The person desiring food, if they have been examined and such specimens shall make a written found to be suitable for such purpose, application to the inspector in charge by an inspector and are labeled as pre- for such permit on Form MP–112 and shall obtain permission from the oper- scribed in this paragraph. ator of the official establishment to ob- (ii) The containers of all such prod- tain the specimens. Permits shall be ucts shall bear a label showing: (A) The issued for a period not longer than one name of the products; (B) the name and year. The permit may be revoked by address of the packer or distributor, the inspector in charge if he deter- and, when the name of the distributor mines after notice and opportunity to is shown, it shall be qualified by such present views is afforded to the per- terms as ‘‘packed for,’’ ‘‘distributed mittee that any such specimens were by,’’ or ‘‘distributors’’; and (C) the offi- not used as stated in the application, cial establishment number of the es- or if the collection or handling of the tablishment where packed. specimens interferes with inspection or (iii) Such products shall not bear the the maintenance of sanitary conditions official inspection legend. in the establishment. The specimens (3)(i) Poultry heads and feet that are referred to in this paragraph shall be collected and handled at an official es- collected and handled only at such tablishment in an acceptable manner time and place and in such manner as may be shipped from the official estab- not to interfere with the inspection or lishment and in commerce directly to to cause any objectionable condition another official establishment for proc- and shall be identified as inedible when essing before export, provided the re- they leave the establishment. ceiving establishment maintains (c) To parts of poultry carcasses that records that: are naturally inedible by humans, such (A) Identify the source of the incom- as entrails and feathers in their nating undenatured poultry product; ural state. (B) Identify the location of the prod- [40 FR 55310, Nov. 28, 1975] uct at all times during processing and preparation for export; and § 381.190 Transactions in slaughtered (C) Contain a written certification poultry and other poultry products from an official of the receiving estab- restricted; vehicle sanitation re- lishment that the undenatured poultry quirements. product intended for export has not (a) No person shall sell, transport, been, and will not be, commingled with offer for sale or transportation, or re- any product intended for consumption ceive for transportation, in commerce in the United States.

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(ii) The receiving establishment may tion which could cause adulteration is only ship the undenatured poultry corrected. Poultry product placed in product intended for export in accord- any means of conveyance that is found ance with the inspection and labeling by the inspector to be in such condi- requirements of paragraph (b)(2) of this tion that the poultry product may have section. become adulterated shall be removed (c) No person, engaged in the busi- from the means of conveyance and han- ness of buying, selling, freezing, stor- dled in accordance with § 381.145(b). ing, or transporting, in or for com- [37 FR 9706, May 16, 1972, as amended at 39 merce, poultry products capable of use FR 4569, Feb. 5, 1974; 40 FR 42338, Sept. 12, as human food, or importing such arti- 1975; 41 FR 23700, June 11, 1976; 60 FR 43358, cles, shall transport, offer for transpor- Aug. 21, 1995] tation, or receive for transportation, in commerce or in any State designated § 381.191 Distribution of inspected under § 381.221, any poultry product products to small lot buyers. which is capable of use as human food For the purpose of facilitating the and is not wrapped, packaged, or other- distribution in commerce of inspected wise enclosed to prevent adulteration poultry products to small lot buyers by airborne contaminants, unless the (such as small restaurants), distribu- railroad car, truck, or other means of tors or jobbers may remove inspected conveyance in which the product is and passed non-consumer-packaged contained or transported is completely poultry carcasses or consumer-pack- enclosed with tight fitting doors or aged poultry products from shipping other covers for all openings. In all containers or immediate containers, cases, the means of conveyance shall be other than consumer packages, and reasonably free of foreign matter (such place them into other containers which as dust, dirt, rust, or other articles or do not bear an official inspection mark: residues), and free of chemical resi- Provided, That the individual non-con- dues, so that product placed therein sumer-packaged carcasses bear the of- will not become adulterated. Any ficial inspection legend and the official cleaning compound, lye, soda solution, establishment number of the establish- or other chemical used in cleaning the ment that processed the articles; and means of conveyance must be thor- the consumer-packaged articles are oughly removed from the means of con- fully labeled in accordance with sub- veyance prior to its use. Such means of part N: And provided further, That the conveyance onto which product is load- other container is marked with the ed, being loaded, or intended to be name and address of the distributor or loaded, shall be subject to inspection jobber and bears the statement ‘‘The by an inspector at any official estab- poultry product contained herein was lishment. The decision whether or not inspected by the U.S.D.A.’’ in the case to inspect a means of conveyance in a of poultry products processed in the specific case, and the type and extent United States, or the statement ‘‘The of such inspection shall be at the In- poultry products contained herein have spection Service’s discretion and shall been approved for importation under be adequate to determine if poultry P.P.I.A.’’ in the case of imported poul- product in such conveyance is, or when try products. moved could become, adulterated. Circumstances of transport that can be § 381.192 Penalties inapplicable to car- reasonably anticipated shall be consid- riers. ered in making said determination. No carrier shall be subject to the These include, but are not limited to, penalties of the Act, other than the weather conditions, duration and dis- penalties for violation of section 11, by tance of trip, nature of product cov- reason of his receipt, carriage, holding, ering, and effect of restowage at stops or delivery, in the usual course of busi- en route. Any means of conveyance ness, as a carrier, of poultry or poultry found upon such inspection to be in products, owned by another person, un- such condition that poultry product less the carrier has knowledge, or is in placed therein could become adulter- possession of facts which would cause a ated shall not be used until such condi- reasonable person to believe that such

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poultry or poultry products were not not be denatured in accordance with inspected or marked in accordance § 381.95. with the provisions of the Act or where (3) Notwithstanding the provisions of otherwise not eligible for transpor- paragraph (b)(1) of this section, animal tation under the Act, or unless the car- food packed in hermetically sealed, re- rier refuses to furnish on request of a tort processed, conventional retail-size representative of the Secretary, the containers, and retail-size packages of name and address of the person from semi-moist animal food need not be de- whom he received such poultry or poul- natured in accordance with § 381.95 if try products, and copies of all docu- the name of the article clearly conveys ments, if any there be, pertaining to the article’s intended use for animal the delivery of the poultry or poultry food and appears on the label in a con- products to such carrier. spicuous manner. (i) Except as provided in paragraph § 381.193 Poultry carcasses, etc., not (ii) of paragraph (b)(3) of this section, intended for human food. the name of the article must be stated (a) Except as provided in paragraph on the label as ‘‘Animal Food,’’ ‘‘Pet (b) of this section, poultry carcasses, Food,’’ or ‘‘(name of species) Food’’ and parts and products thereof, that (e.g., ‘‘Dog Food’’ or ‘‘Cat Food’’). To are not intended for use as human food be considered conspicuous, the name of may, after they have been denatured as the article, wherever it appears on the prescribed in § 381.95, be bought, sold, label, must be stated in letters at least transported, offered for sale or trans- twice as high, wide, and thick as the portation, or received for transpor- letters indicating the presence in the tation, in commerce, or imported, even article of any ingredients derived from though they do not comply with all the carcasses of poultry. provisions of the regulations, provided (ii) Notwithstanding the provisions of they are marked ‘‘Not fit for human paragraph (i) of paragraph (b)(3) of this section, the article’s name may be food.’’ These requirements do not apply stated on the label to show that it is or to parts of poultry carcasses that are contains poultry carcass-source mate- naturally inedible by humans, such as rial and that the article is for animals; entrails. e.g., ‘‘Chicken for Pets’’ or ‘‘Turkey (b)(1) Except as provided in para- Dinner for Cats’’: Provided, That the graphs (b) (2), (3), and (4) of this sec- entire name of the article is stated, tion, no animal food processed, in wherever it appears on the label, as an whole or in part, from materials de- individual, contiguous unit, whether rived from the carcasses of poultry in stated on a single line or more than an official establishment or elsewhere, one line, and the letters denoting the shall be bought, sold, transported, of- article’s intended use for animal food fered for sale or transportation, or re- are at least as high, wide, and thick as ceived for transportation in commerce, the letters indicating the presence of or imported, unless: material derived from any poultry car- (i) It is properly identified as animal cass. However, when the label bears on food; its principal display panel a vignette (ii) It is not represented as being a which pictures, in clearly recognizable human food; and form and size, one or more animals of (iii) It has been denatured as pre- the species for which the article’s name scribed in § 381.95 so as to be readily indicates the article is intended, the distinguishable from an article of letters used to state the article’s in- human food. tended use shall be at least one-half as (2) Notwithstanding the provisions of high, wide, and thick as the letters paragraph (b)(1) of this section, an ani- used in the article’s name or other let- mal food that consists of less than 5 ters indicating the presence of mate- percent of parts or products of the car- rial derived from any poultry carcass, casses of poultry and that is not rep- but shall not be less than 1⁄8 inch high. resented by labeling or appearance or The letters used to state the article’s otherwise as being a human food or as intended use may be separated from a product of the poultry industry need the article’s name by the vignette.

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(iii) Letters used to denote the in- ments eligible to receive them under tended use of the article must contrast paragraph (a) of this section. as markedly with their background as (c) Unload en route to any establish- the letters indicating the presence in ment eligible to receive them under the article of poultry carcass-source paragraph (a) of this section, any dead, material contrast with their back- dying, disabled, or diseased poultry or ground. parts of the carcasses of any poultry (4) The requirements of this part do that died otherwise than by slaughter, not apply to livestock or poultry feed which are transported in commerce or manufactured from processed poultry imported by any such person: Provided, byproducts (such as poultry byproduct That any such dead, dying, disabled, or meal, hydrolyzed poultry feathers, and diseased poultry, or parts of carcasses hydrolyzed poultry byproducts aggre- may be unloaded from a means of con- gate), or to processed dry animal food. veyance en route where necessary in case of a wreck or otherwise extraor- [49 FR 47479, Dec. 5, 1984] dinary emergency, and may be reloaded § 381.194 Transportation and other into another means of conveyance; but transactions concerning dead, in all such cases, the carrier shall im- dying, disabled, or diseased poultry, mediately report the facts by telegraph and parts of carcasses of poultry or telephone to the Director, Compli- that died otherwise than by slaugh- ance Staff, Meat and Poultry Inspec- ter. tion Program, Food Safety and Inspec- No person engaged in the business of tion Service, U.S. Department of Agri- buying, selling, or transporting in com- culture, Washington, DC 20250. merce, or importing any dead, dying, [40 FR 55310, Nov. 28, 1975] disabled, or diseased poultry or parts of the carcasses of any poultry that died otherwise than by slaughter shall: Subpart T—Imported Poultry (a) Sell, transport, offer for sale or Products transportation or receive for transportation, in commerce, any dead, dying, § 381.195 Definitions; requirements for disabled, or diseased poultry, or parts importation into the United States. of the carcasses of any poultry that (a) When used in this part, the fol- died otherwise than by slaughter, un- lowing terms are defined to mean: less such poultry and parts are con- (1) Import (imported). To bring within signed and delivered, without avoidable the territorial limits of the United delay, to establishments of animal food States whether that arrival is accom- manufacturers, renderers, or collection plished by land, air, or water. stations that are registered as required (2) Offer(ed) for entry. The point at by § 381.179, or to official establish- which the importer presents the im- ments that operate under Federal in- ported product for reinspection. spection, or to establishments that op- (3) Entry (entered). The point at which erate under a State or Territorial in- imported product offered for entry re- spection system approved by the Sec- ceives reinspection and is marked with retary as one that imposes require- the official mark of inspection, as re- ments at least equal to the Federal required by § 381.204. quirements for purposes of section 5(c) (b) No slaughtered poultry, or parts of the Act. or products thereof, shall be imported (b) Buy in commerce or import any into the United States unless they are dead, dying, disabled, or diseased poul- healthful, wholesome, fit for human try or parts of the carcasses of any food, not adulterated, and contain no poultry that died otherwise than by dye, chemical, preservative, or ingre- slaughter, unless he is an animal food dient which renders them unhealthful, manufacturer or renderer and is reg- unwholesome, adulterated, or unfit for istered as required by § 381.179, or is the human food and they also comply with operator of an establishment inspected the regulations prescribed in this sub- as required by paragraph (a) of this sec- part to assure that they comply with tion and such poultry or parts of car- the standards provided for in the Act: casses are to be delivered to establish- Provided, That the provisions of this

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subpart apply to such articles only if (A) Organizational structure and they are capable of use as human food. staffing, so as to insure uniform en- (c) Except as provided in § 381.207, forcement of the requisite laws and slaughtered poultry and other poultry regulations in all establishments products may be imported only if they throughout the system at which poul- were processed solely in countries list- try products are processed for export to ed in § 381.196(b). Slaughtered poultry the United States; may be imported only if it qualifies as (B) Ultimate control and supervision ready-to-cook poultry. by the national government over the [37 FR 9706, May 16, 1972, as amended at 40 official activities of all employees or FR 42338, Sept. 12, 1975; 54 FR 41049, Oct. 5, licensees of the system; 1989; 79 FR 56233, Sept. 19, 2014] (C) The assignment of competent, qualified inspectors; § 381.196 Eligibility of foreign coun- (D) Authority and responsibility of tries for importation of poultry national inspection officials to enforce products into the United States. the requisite laws and regulations gov- (a)(1) Whenever it shall be deter- erning poultry inspection and to cer- mined by the Administrator that the tify or refuse to certify poultry prod- system of poultry inspection main- ucts intended for export; tained by any foreign country, with re- (E) Adequate administrative and spect to establishments preparing prod- technical support; ucts in such country for export to the (F) The inspection, sanitation, qual- United States, insures compliance of ity, species verification, and residue such establishments and their poultry standards applied to products produced products, with requirements equivalent in the United States. to all the provisions of the Act and the (G) Other requirements of adequate regulations in this part which are ap- inspection service as required by the plied to official establishments in the regulations. United States, and their poultry prod- (ii) The legal authority for the sys- ucts, and that reliance can be placed tem and the regulations thereunder upon certificates required under this shall impose requirements equivalent subpart from authorities of such for- to those governing the system of poul- eign country, notice of that fact will be try inspection organized and main- given by including the name of such tained in the United States with re- foreign country in paragraph (b) of this spect to: section. Thereafter, poultry products (A) Ante mortem inspection of poul- processed in such establishments which try for slaughter, which shall be per- are certified and approved in accord- formed by veterinarians or by other ance with paragraph (a)(3) of this sec- employees or licensees of the system tion shall be eligible, so far as the reg- under the direct supervision of veteri- ulations in this part are concerned, for narians; importation into the United States (B) Post mortem inspection of car- from such foreign country after appli- casses and parts thereof at time of cable requirements of this part have slaughter, performed by veterinarians been met. or other employees or licensees of the (2) The determination of accept- system under the direct supervision of ability of a foreign poultry inspection veterinarians; system for purposes of this section (C) Official controls by the national shall be based on an evaluation of the government over establishment con- foreign program in accordance with the struction, facilities, and equipment; following requirements and procedures: (D) Direct and continuous official su- (i) The system shall have a program pervision of slaughtering of poultry organized and administered by the na- and processing of poultry products, by tional government of the foreign coun- the assignment of inspectors to estab- try. The system as implemented must lishments certified under paragraph provide standards equivalent to those (a)(3) of this section to assure that of the Federal system of poultry in- adulterated or misbranded poultry spection in the United States with re- products are not processed for export spect to: to the United States;

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(E) Complete separation of establish- (A) Periodic supervisory visits by a ments certified under subparagraph (3) representative of the foreign inspection of this paragraph from establishments system to each establishment certified not certified, and the maintenance of a in accordance with paragraph (a)(3) of single standard of inspection and sani- this section to ensure that require- tation throughout all certified estab- ments referred to in paragraphs lishments; (a)(2)(ii)(A) through (H) of this section (F) Requirements for sanitation at are being met: Provided, That such vis- certified establishments and for sani- its are not required with respect to any tary handling of poultry products; establishment during a period when the (G) Official controls over condemned establishment is not operating or is material until destroyed or removed not engaged in producing products for and thereafter excluded from the estab- exportation to the United States; lishment; (B) Written reports prepared by the (H) A Hazard Analysis and Critical representative of the foreign inspection Control Point (HACCP) system, as set system who has conducted a super- forth in part 417 of this chapter. visory visit, documenting his or her findings with respect to the require- (I) Other matters for which requirements referred to in paragraphs ments are contained in the Act or the (a)(2)(ii)(A) through (a)(2)(ii)(H) of this regulations in this part. section, copies of which shall be made (iii) Countries desiring to establish available to the representative of the eligibility for importation of poultry Department at the time of the rep- products into the United States may resentative’s review upon request by request a determination of eligibility that representative to a responsible by presenting copies of the laws and foreign inspection official: Provided, regulations on which the foreign poul- that such reports are not required dur- try inspection system is based and such ing a period when the establishment is other information as the Adminis- not operating or not engaged in pro- trator may require with respect to ducing products for exportation to the matters enumerated in paragraphs United States. (a)(2) (i) and (ii). Determination of eli- (C) Random sampling and testing at gibility is based on a study of the docu- the point of slaughter of carcasses, in- ments and other information presented cluding internal organs and fat, for res- and an initial review of the system in idues identified by the exporting coun- operation by a representative of the try’s inspection authorities or by this Department using the criteria listed in Agency as potential contaminants, in paragraphs (a)(2) (i) and (ii) of this sec- accordance with sampling and analyt- tion. Maintenance of eligibility of a ical techniques approved by the Admin- country for importation of poultry istrator: Provided, that such testing is products into the United States de- required only on samples taken of car- pends on the results of periodic reviews casses from which poultry or poultry of the foreign poultry inspection sys- products intended for importation into tem in operation by a representative of the United States are produced. the Department, and the timely sub- (3) Only those establishments that mission of such documents and other are determined and certified to the information related to the conduct of Agency by a responsible official of the the foreign inspection system as the foreign meat inspection system as fully Administrator may find pertinent to meeting the requirements of para- and necessary for the determinations graphs (a)(2)(i) and (ii) of this section required by this section. are eligible to have their products im- (iv) The foreign inspection system ported into the United States. Estab- must maintain a program to assure lishment eligibility is subject to review that the requirements referred to in by the Agency (including observations this section, equivalent to those appli- of the establishments by Program rep- cable to the Federal system in the resentatives at times prearranged with United States, are being met. The pro- the foreign meat inspection system of- gram as implemented must provide for ficials). Foreign establishment certifi- the following: cations must be renewed annually.

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Notwithstanding certification by a for- with requirements equivalent to all the eign official, the Administrator may requirements of the Act and the regu- terminate the eligibility of any foreign lations as applied to official establish- establishment for the importation of ments in the United States; or that re- its products into the United States if it liance cannot be placed upon certifi- does not comply with the requirements cates required under this subpart from listed in paragraphs (a)(2)(i) and (ii) of authorities of such foreign country; or this section, or if current establish- that, for lack of current information ment information cannot be obtained. concerning the system of poultry in- The Administrator will provide reason- spection being maintained by such for- able notice to the foreign government eign country, such foreign country of the proposed termination of any for- should be required to reestablish its eign establishment, unless a delay in eligibility for listing. terminating its eligibility could result (b) It has been determined that poul- in the importation of adulterated or try products from the following coun- misbranded product. tries, covered by foreign poultry in- (i) For a new establishment or any spection certificates of the country of establishment for which information origin as required by § 381.197, are eligi- from last year’s electronic certifi- ble under the regulations in this sub- cation or paper certificate has changed, part for entry into the United States, the certification or certificate must after inspection and marking as re- contain: The date; the foreign country; quired by the applicable provisions of the foreign establishment’s name, ad- this subpart: 1 dress, and foreign establishment number; the foreign official’s title; the for- Australia (ratites only). eign official’s signature (for paper cer- Canada. Chile. tificates only); the type of operation(s) France. conducted at the establishment (e.g., Great Britain. slaughter, processing, storage, export- Hong Kong. ing warehouse); and the establish- Israel. ment’s eligibility status (e.g., new or Mexico. 2 relisted (if previously delisted)). New Zealand (ratites only). Slaughter and processing establish- People’s Republic of China. 2 ment certifications must address the Republic of Korea species and type of products produced [37 FR 9706, May 16, 1972, as amended at 43 at the establishment (e.g., the process FR 8117, Feb. 28, 1978; 52 FR 23021, June 17, category). 1987; 54 FR 41049, Oct. 5, 1989; 54 FR 43951, (ii) If the establishment information Oct. 30, 1989; 60 FR 38668, July 28, 1995; 61 FR provided on the preceding year’s elec- 38868, July 25, 1996; 64 FR 49645, Sept. 14, 1999; tronic foreign establishment certifi- 68 FR 37071, June 23, 2003; 71 FR 20871, Apr. cation or paper certificate, as required 24, 2006; 71 FR 43961, Aug. 3, 2006; 72 FR 61796, in paragraph (a)(3)(i) of this section, Nov. 1, 2007; 79 FR 16661, Mar. 26, 2014; 79 FR has not changed, the certification or 56234, Sept. 19, 2014] certificate must contain: The date, the § 381.197 Foreign inspection certificate foreign country, the foreign establish- requirements. ment’s name, the foreign official’s title and signature (for paper certificates (a) Except as provided in §§ 381.207 only). and 381.209, each consignment imported (4) Poultry products from foreign into the United States must have an countries not listed in paragraph (b) of this section are not eligible for impor- 1 Listing of any country in this section tation into the United States, except does not relieve the poultry products of such as provided by §§ 381.207 and 381.209. The country from applicable requirements under listing of any foreign country under other Federal laws. 2 this section may be withdrawn when- May export to the United States only processed poultry products slaughtered ever it shall be determined by the Ad- under Federal inspection in the United ministrator that the system of poultry States or in a country eligible to export inspection maintained by such foreign slaughtered poultry products to the United country does not assure compliance States.

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electronic foreign inspection certifi- § 381.198 Import inspection applica- cation or a paper foreign inspection tion. certificate issued by an official of the (a) Applicants must submit an im- foreign government agency responsible port inspection application to apply for for the inspection and certification of the inspection of any product offered the product. for entry. Applicants may apply for in- (b) An official of the foreign govern- spection using a paper or electronic ap- ment must certify that any product described on any official certificate was plication form. produced in accordance with the regu- (b) Import inspection applications for latory requirements in § 381.196. each consignment must be submitted (c) The electronic foreign inspection (electronically or on paper) to FSIS in certification must be in English, be advance of the shipment’s arrival at transmitted directly to FSIS before the the official import establishment product’s arrival at the official import where the product will be reinspected, inspection establishment, and be avail- but no later than when the entry is able to import inspection personnel. filed with U.S. Customs and Border (d) The paper foreign inspection cer- Protection. tificate must accompany each consign- (c) The provisions of this section do ment; be submitted to import inspec- not apply to products that are exempt- tion personnel at the official import ined from inspection by §§ 381.207 and spection establishment; be in English; 381.209. and bear the official seal of the foreign government responsible for the inspec- [79 FR 56234, Sept. 19, 2014] tion of the product, and the name, § 381.199 Inspection of poultry prod- title, and signature of the official au- ucts offered for entry. thorized to issue inspection certificates for products imported to the United (a)(1) Except as provided in § 381.209 States. and paragraph (c) of this section, all (e) The electronic foreign inspection slaughtered poultry and poultry prod- certification and paper foreign inspec- ucts offered for entry from any foreign tion certificate must contain: country shall be reinspected by a Pro- (1) The date; gram import inspector before they (2) The foreign country of export and shall be allowed entry into the United the producing foreign establishment States. number; (2) Every lot of product shall rou- (3) The species used to produce the tinely be given visual inspection for product and the source country and appearance and condition, and checked foreign establishment number, if the for certification and label compliance. source materials originate from a (3) The electronic inspection system country other than the exporting coun- shall be consulted for reinspection in- try; structions. The electronic inspection (4) The product’s description, includ- system will assign reinspection levels ing the process category, the product and procedures based on established category, and the product group; sampling plans and established product (5) The name and address of the im- and plant history. porter or consignee; (4) When the inspector deems it nec- (6) The name and address of the ex- essary, the inspector may sample and porter or consignor; inspect lots not designated by the elec- (7) The number of units (pieces or tronic inspection system. containers) and the shipping or identi- (b) Inspectors may take, without cost fication mark on the units; to the United States, from each con- (8) The net weight of each lot; and signment of poultry products offered (9) Any additional information the for entry, such samples of the products Administrator requests to determine as are deemed necessary to determine whether the product is eligible to be the eligibility of the products for entry imported into the United States. into the commerce of the United [79 FR 56234, Sept. 19, 2014] States.

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(c) Poultry products imported under the necessary incubation facilities in § 381.207 shall not be sampled and in- accordance with § 381.309(d)(1)(i) of this spected under this section unless there subchapter. is reason for suspecting the presence (3) Sampling plans and acceptance therein of a substance in violation of levels as prescribed in paragraphs (d)(1) that section, and in such case they and (d)(2) of this section may be ob- shall be sampled and inspected in ac- tained, upon request, from Inter- cordance with paragraph (a) of this sec- national Programs, Food Safety and tion. Inspection Service, U.S. Department of (d) In addition to the provisions spec- Agriculture, Washington, DC 20250. ified in paragraphs (a), (b), and (c) of (e) All products, required by this part this section, the following require- to be inspected, shall be inspected only ments apply to imported canned prod- at an official establishment or at an of- uct. ficial import inspection establishment (1) Imported canned products are re- approved by the Administrator as pro- quired to be sound, healthful, properly vided in this section. Such approved of- labeled, wholesome, and otherwise not ficial import inspection establishments adulterated at the time the products will be listed in the Meat, Poultry and are offered for importation into the Egg Product Inspection Directory, pub- United States. Provided other require- lished by the Food Safety and Inspec- ments of this part are met, the deter- tion Service. The listing will cat- mination of the acceptability of the egorize the kind or kinds of product product and the condition of the con- which may be inspected at each official tainers shall be based on the results of import inspection establishment, based an examination of a statistical sample on the adequacy of the facilities for drawn from the consignment as pro- making such inspections and handling vided in paragraph (a) of this section. If such products in a sanitary manner. the inspector determines, on the basis (f) Owners or operators of establish- of the sample examination, that the ments, other than official establish- product does not meet the requirements, who want to have import in- ments of the Act and regulations there- spections made at their establish- under, the consignment shall be re- ments, shall apply to the Adminis- fused entry. However, a consignment trator for approval of their establish- rejected for container defects but oth- ments for such purpose. Application erwise acceptable may be reoffered for shall be made on a form furnished by inspection under the following condi- the Program, Food Safety and Inspec- tions: tion Service, U.S. Department of Agri- (i) If the defective containers are not culture, Washington, DC, and shall in- indicative of an unsafe or unstable clude all information called for by that product as determined by the Adminis- form. trator; (g) Approval for Federal import in- (ii) If the number and kinds of con- spection shall be in accordance with tainer defects found in the original subpart D of this part. sample do not exceed the limits speci- (h) Owners or operators of establish- fied for this purpose in FSIS guide- ments at which import inspections of lines; and product are to be made shall furnish (iii) If the defective containers in the adequate sanitary facilities and equip- consignment have been sorted out and ment for examination of such product. exported or destroyed under the super- The requirements of §§ 381.21 and 381.36, vision of an inspector. and part 416 of this chapter shall apply (2) Representative samples of canned as conditions for approval of establish- product designated by the Adminis- ments as official import inspection es- trator in instructions to inspectors tablishments to the same extent and in shall be incubated under the super- the same manner as they apply with vision of such inspectors in accordance respect to official establishments. with § 381.309 (d)(1)(ii), (d)(1)(iii), (i) The Administrator is authorized (d)(1)(iv)(c), (d)(1)(v), (d)(1)(vii), and to approve any establishment as an of- (d)(1)(viii) of this subchapter. The im- ficial import inspection establishment porter or his/her agent shall provide provided that an application has been

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filed and drawings have been submitted and if arriving by water, from the in accordance with the requirements of wharf where first unloaded at such paragraphs (c) and (d) of this section port, to any place other than the place and he determines that such establish- designated in accordance with this sub- ment meets the requirements under part as the place where the same shall paragraph (e) of this section. Any ap- be inspected; and no product shall be plication for inspection under this sec- conveyed in any manner other than in tion may be denied or refused in ac- compliance with this subpart. cordance with the rules of practice in (c) The consignee, or his agent, shall part 500 of this chapter. furnish such facilities and shall provide (j) Approval of an official import in- such assistance for handling and mark- spection establishment may be with- ing poultry products offered for entry drawn in accordance with applicable as the inspector may require. rules of practice if it is determined [37 FR 9706, May 16, 1972, as amended at 51 that the sanitary conditions are such FR 37710, Oct. 24, 1986; 54 FR 41050, Oct. 5, that the product is rendered adulter- 1989; 56 FR 65180, Dec. 16, 1991] ated, that such action is authorized by section 21(b) of the Federal Water Pol- § 381.201 Means of conveyance and lution Control Act, as amended (84 equipment used in handling poultry products offered for entry to be Stat. 91), or that the requirements of maintained in sanitary condition. paragraph (e) of this section were not complied with. Approval may also be Compartments of steamships, rail- withdrawn in accordance with section road cars, and other means of convey- 401 of the Act and applicable rules of ance transporting any poultry product practice. to the United States, and all chutes, (k) A special official number shall be platforms, racks, tables, tools, uten- assigned to each official import inspec- sils, and all other devices used in mov- tion establishment. Such number shall ing and handling any poultry product be used to identify all products in- offered for entry into the United States, shall be maintained in a sani- spected and passed for entry at the es- tary condition. tablishment. [37 FR 9706, May 16, 1972, as amended at 49 § 381.202 Poultry products offered for FR 36819, Sept. 20, 1984; 51 FR 45633, Dec. 19, entry; reporting of findings to cus- 1986; 54 FR 275, Jan. 5, 1989; 54 FR 41050, Oct. toms; handling of articles refused 5, 1989; 79 FR 56234, Sept. 19, 2014] entry; appeals, how made; denaturing procedures. § 381.200 Poultry products offered for (a)(1) Program inspectors shall report entry, retention in customs custody; their findings as to any product which delivery under bond; movement has been inspected in accordance with prior to inspection; handling; facili- this part, to the Director of Customs at ties and assistance. the original port of entry. (a) No slaughtered poultry or other (2) When product has been identified poultry product required by this sub- as ‘‘U.S. refused entry,’’ the inspector part to be inspected shall be released shall request the Director of Customs from customs custody prior to inspec- to refuse admission to such product tion, but such product may be deliv- and to direct that it be exported by the ered to the consignee, or his agent, owner or consignee within the time prior to inspection, if the consignee specified in this section, unless the shall furnish a bond, in form prescribed owner or consignee, within the speci- by the Secretary of the Treasury, con- fied time, causes it to be destroyed by ditioned that the product shall be re- disposing of it under the supervision of turned, if demanded, to the collector of a Program employee so that the prod- the port where the same is offered for uct can no longer be used as human clearance through the customs. food, or by converting it to animal food (b) Except as provided in paragraph uses, if permitted by the Food and (a) of this section, no product required Drug Administration. The owner or by this subpart to be inspected shall be consignee of the refused entry product moved, prior to inspection, from the shall not transfer legal title to such port of arrival where first unloaded, product, except to a foreign consignee

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for direct and immediate exportation, pursuant to paragraph (a)(2) of this sec- or an end user, e.g., an animal food tion may be returned to the United manufacturer or a renderer, for de- States under any circumstance. Any struction for human food purposes. such product so returned to the United ‘‘Refused entry’’ product must be deliv- States shall be subject to administra- ered to and used by the manufacturer tive detention in accordance with sec- or renderer within the 45-day time tion 19 of the Act, and seizure and con- limit. Even if such title is illegally demnation in accordance with section transferred, the subsequent purchaser 20 of the Act. will still be required to export the (b) Upon the request of the Director product or have it destroyed as speci- of Customs at the port where a product fied in the notice under paragraph is offered for clearance through the (a)(4) of this section. customs, the consignee of the product (3) No lot of product which has been shall, at the consignee’s own expense, refused entry may be subdivided during immediately return to the Director disposition pursuant to paragraph any product which has been delivered (a)(2) of this section, except that re- to consignee under this subpart and moval and destruction of any damaged subsequently designated ‘‘U.S. Refused or otherwise unsound product from a Entry’’ or found in any request not to lot destined for reexportation is per- comply with the requirements in this mitted under supervision of USDA subpart. prior to exportation. Additionally, (c) Except as provided in § 381.200(a) such refused entry lot may not be or (b), no person shall remove or cause shipped for export from any port other to be removed from any place des- than that through which the product ignated as the place of inspection, any came into the United States without poultry product which the regulations the expressed consent of the Adminis- in this subpart require to be marked in trator, based on full information con- any way, unless the same has been cerning the product’s disposition, in- clearly and legibly marked in compli- cluding the name of the vessel and the ance with this subpart. date of export. For the purposes of this (d) Any person receiving inspection paragraph, the term ‘‘lot’’ shall refer service may, if dissatisfied with any to that product identified on MP Form decision of an inspector relating to any 410 in the original request for inspec- inspection, file an appeal from such de- tion for importation pursuant to cision: Provided, That such appeal is § 381.198. filed within 48 hours from the time the (4) The owner or consignee shall have decision was made. Any such appeal 45 days after notice is given by FSIS to from a decision of an inspector shall be the Director of Customs at the original made to his/her immediate supervisor port of entry to take the action re- having jurisdiction over the subject quired in paragraph (a)(2) of this sec- matter of the appeal, and such super- tion for ‘‘refused entry’’ product. Ex- visor shall determine whether the in- tension beyond the 45-day period may spector’s decision was correct. Review be granted by the Administrator when of such appeal determination, when re- extreme circumstances warrant it; e.g., quested, shall be made by the imme- a dock workers’ strike or an unforesee- diate supervisor of the employee of the able vessel delay. Department making the appeal deter- (5) If the owner or consignee fails to mination. The cost of any such appeal take the required action within the shall be borne by the appellant if the time specified under paragraph (a)(4) of Administrator determines that the ap- this section, the Department will take peal is frivolous. The charges for such such actions as may be necessary to ef- frivolous appeal shall be at the rate of fectuate its order to have the product $9.28 per hour for the time required to destroyed for human food purposes. make the appeal inspection. The poul- The Department shall seek court costs try or poultry products involved in any and fees, storage, and proper expenses appeal shall be identified by U.S. rein the appropriate forum. tained tags and segregated in a manner (6) No product which has been refused approved by the inspector pending entry and exported to another country completion of an appeal inspection.

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(e) All condemned carcasses, or con- ing under the supervision of an inspec- demned parts of carcasses, or other tor. condemned poultry products, except [37 FR 9706, May 16, 1972, as amended at 48 those condemned for biological resi- FR 15890, Apr. 13, 1983; 50 FR 19908, May 13, dues, shall be disposed of by one of the 1985; 51 FR 37709, Oct. 24, 1986; 53 FR 17015, following methods, under the super- May 13, 1988; 54 FR 50735, Dec. 11, 1989; 60 FR vision of an inspector of the Inspection 67458, Dec. 29, 1995] Service. (Facilities and materials for carrying out the requirements in this § 381.203 Products offered for entry; section shall be furnished by the offi- charges for storage, cartage, and cial establishments.) labor with respect to products which are refused entry. (1) Steam treatment (which shall be accomplished by processing the con- All charges for storage, cartage, and demned product in a pressure tank labor with respect to any product of- under at least 40 pounds of steam pres- fered for entry which is refused entry sure) or thorough cooking in a kettle pursuant to the regulations shall be or vat, a sufficient time to effectively paid by the owner or consignee and, in destroy the product for human food default of such payment, shall con- purposes and preclude dissemination of stitute a lien against any other prod- disease through consumption by ani- ucts offered for entry thereafter by or mals. (Tanks and equipment used for for such owner or consignee. this purpose or for rendering or pre- [54 FR 41050, Oct. 5, 1989] paring inedible products shall be in rooms or compartments separate from § 381.204 Marking of poultry products those used for the preparation of edible offered for entry; official import in- products. There shall be no direct con- spection marks and devices. nection by means of pipes, or other- (a) Except for products offered for wise, between tanks containing ined- entry from Canada, poultry products ible products and those containing edi- which upon reinspection are found to ble products.) be acceptable for entry into the United (2) Incineration or complete destruc- States shall be marked with the offi- tion by burning. cial inspection legend shown in para- (3) Chemical denaturing, which shall graph (b) of this section. Such inspec- be accomplished by the liberal application legend shall be placed upon such tion to all carcasses and parts thereof, products only after completion of offi- of: cial import inspection and product ac- (i) Crude carbolic acid, ceptance. (ii) Kerosene, fuel oil, or used crank- (b) The official mark for marking case oil, or poultry products offered for entry as (iii) Any phenolic disinfectant con- ‘‘U.S. inspected and passed’’ shall be in forming to commercial standards CS the following form, and any device ap- 70–41 or CS 71–41 which shall be used in proved by the Administrator for apply- at least 2 percent emulsion or solution. ing such mark shall be an official de- (4) Any other substances or method vice. 2 that the Administrator approves in specific cases, which will denature the poultry product to the extent necessary to accomplish the purposes of this section. (5) Carcasses and parts of carcasses condemned for biological residue shall be disposed of in accordance with para- 2 The number ‘‘I–42’’ is given as an example graph (e)(2) of this section or by bury- only. The establishment number of the official establishment or official import inspection establishment where the product was inspected shall be shown on each stamp impression.

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where the inspection is to be performed. (1) The written procedure for controlled pre-stamping should be in the form of a letter and shall include the following: (i) That stamping under this subpart will be limited to those lots of product which can be inspected on the day that certificates for the product are examined; (ii) That all products which have been pre-stamped will be stored in the facility where the import inspection will occur; (iii) That inspection marks applied under this part will be removed from any lot of product subsequently refused entry on the day the product is rejected; and FIGURE 1 (iv) That the establishment will (c) When products are refused entry maintain a daily stamping log con- into the United States, the official taining the following information for mark to be applied to the products re- each lot of product: the date of inspection, the country of origin, the foreign fused entry shall be in the following establishment number, the product form: name, the number of units, the shipping container marks, and the MP–410 number covering the product to be inspected. The daily stamping log must be retained by the establishment in accordance with the requirements of § 381.177. (2) An establishment’s controlled pre- stamping privilege may be cancelled orally or in writing by the inspector FIGURE 2 who is supervising its enforcement (d) The import warning notice pre- whenever the inspector finds that the scribed in § 381.200(c) is an official establishment has failed to comply mark. with the provisions of this subpart or (e) The ordering and manufacture of any conditions imposed pursuant brands shall be in accordance with the thereto. If the cancellation is oral, the provisions contained in § 317.3(c) of the decision and the reasons therefor shall Federal meat inspection regulations. be confirmed in writing, as promptly as (f) The inspection legend may be circumstances allow. Any person whose controlled pre-stamping privilege has placed on containers of product before been cancelled may appeal the decision completion of official import inspec- to the Administrator, in writing, with- tion if the containers are being in- in ten (10) days after receiving written spected by an import inspector who re- notification of the cancellation. The ports to an Import Field Office Super- appeal shall state all of the facts and visor, the product is not required to be reasons upon which the person relies to held at the establishment pending the show that the controlled pre-stamping receipt of laboratory test results; and a was wrongfully cancelled. The Admin- written procedure for controlled istrator shall grant or deny the appeal, stamping, submitted by the import es- in writing, stating the reasons for such tablishment and approved by the Direc- decision, as promptly as circumstances tor, Import Inspection Division, is on allow. If there is a conflict as to any file at the import inspection facility material fact, a hearing shall be held

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to resolve such conflict. Rules of prac- the establishment in which the product tice concerning such a hearing will be was processed, and the inspection mark adopted by the Administrator. The of the country of origin. Labeling on cancellation of the controlled pre- shipping containers shall be examined stamping privilege will be in effect at the time of inspection in the United until there is a final determination in States and if found to be false or mis- the proceeding. leading, the product shall be refused (Approved by the Office of Management and entry. All labeling used with a shipping Budget under control number 0583–0015) container of imported poultry products must be approved in accordance with [51 FR 37710, Oct. 24, 1986, as amended at 53 subpart N of this part. FR 17015, May 13, 1988; 54 FR 41050, Oct. 5, 1989] [37 FR 9706, May 16, 1972, as amended at 54 FR 41050, Oct. 5, 1989; 60 FR 67458, Dec. 29, § 381.205 Labeling of immediate con- 1995] tainers of poultry products offered for entry. § 381.207 Small importations for con- (a) Immediate containers of poultry signee’s personal use, display, or products imported into the United laboratory analysis. States shall bear a label printed in Any poultry product (other than one English showing in accordance with which is forbidden entry by other Fed- subpart N of this part all information eral law or regulation) from any coun- required by that section (except that try in quantities of less than 50 pounds the inspection mark and establishment net weight, exclusively for the personal number assigned by the foreign poultry use of the consignee, or for display or inspection system and certified to the laboratory analysis by the consignee, Inspection Service shall be shown in- and not for sale or distribution; which stead of the official dressed poultry is sound, healthful, wholesome, and fit identification mark or other official infor human food, and which is not adul- spection legend, and official establish- terated and contains no substance not ment number); and in addition the permitted by the Act or regulations, label shall show the name of the coun- may be imported into the United try of origin preceded by the words States without a foreign inspection ‘‘Product of,’’ which statement shall certificate, and such product is not re- appear immediately under the name of quired to be inspected upon arrival in the product. the United States and may be shipped (b) The labels shall not be false or to the consignee without further re- misleading in any respect. striction under this part, except as pro- (c) All marks and other labeling for vided in § 381.199(c): And provided, That use on or with immediate containers the Department may with respect to must be approved for use by the Food any specific importation, require that Safety and Inspection Service in ac- the consignee certify that such product cordance with part 412 of this chapter is exclusively for the personal use of before products bearing such marks said consignee, or for display or labora- and other labeling will be permitted for tory analysis by said consignee, and entry into the United States. not for sale or distribution. [37 FR 9706, May 16, 1972, as amended at 39 [37 FR 9706, May 16, 1972, as amended at 54 FR 4569, Feb. 5, 1974; 54 FR 41050, Oct. 5, 1989; FR 41050, Oct. 5, 1989] 60 FR 67458, Dec. 29, 1995; 78 FR 66838, Nov. 7, 2013] § 381.208 Poultry products offered for entry and entered to be handled § 381.206 Labeling of shipping con- and transported as domestic; entry tainers of poultry products offered into official establishments; trans- for entry. portation. Shipping containers of imported (a) All poultry products, after entry poultry products are required to bear into the United States in compliance in a prominent and legible manner the with this subpart, shall be deemed and name of the product, the name of the treated and, except as provided in country of origin, the foreign inspec- § 381.207, shall be handled and trans- tion system establishment number of ported as domestic products, and shall

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be subject to the applicable provisions Act, any other Federal law, or the laws of this part and to the provisions of the of any State or territory, or the Dis- Poultry Products Inspection Act and trict of Columbia; or that it has been the Federal Food, Drug, and Cosmetic or is intended to be distributed in vio- Act. lation of the provisions of the Act, any (b) Poultry products entered in ac- other Federal law, or the laws of any cordance with this subpart may, sub- State or territory, or the District of ject to the provisions of the regula- Columbia. tions, be taken into official establishments and be mixed with or added to § 381.211 Method of detention; form of poultry products that are inspected detention tag. and passed or exempted from inspection in such establishments. An authorized representative of the (c) Imported poultry products which Secretary shall detain any poultry or have been inspected, passed, and other article to be detained under this marked under this subpart may be subpart, by affixing an official ‘‘U.S. transported in commerce, only upon Detained’’ tag (FSIS Form 8400–2) to compliance with the applicable regula- such article. tions. [55 FR 47843, Nov. 16, 1990] [37 FR 9706, May 16, 1972, as amended at 54 FR 41050, Oct. 5, 1989] § 381.212 Notification of detention to the owner of the poultry or other § 381.209 Returned United States in- article, or the owner’s agent, and spected and marked poultry prod- person having custody. ucts; exemption. (a) When any poultry or other article Poultry products which have been in- is detained under this subpart, an au- spected and passed by the U.S. Depart- ment of Agriculture and are so marked, thorized representative of the Sec- and are returned from foreign coun- retary shall: tries, may be imported if they are not (1) Orally notify the immediate cus- adulterated or misbranded at the time todian of the poultry or other article of such return. Such products are ex- detained, and empted from further requirements (2) Promptly furnish a copy of a com- under this part. Such returned ship- pleted ‘‘Notice of Detention’’ (FSIS ments shall be reported to the Admin- Form 8080–1) to the immediate custo- istrator by letter prior to arrival at the dian of the detained poultry or other United States port of entry. article. (b) If the owner of the detained poul- Subpart U—Detention; Seizure and try or other article, or the owner’s Condemnation; Criminal Offenses agent, is not the immediate custodian at the time of detention and if the § 381.210 Poultry and other articles owner, or owner’s agent, can be subject to administrative detention. ascertained and notified, an authorized Any poultry carcass, or part thereof; representative of the Secretary shall or any product made wholly or in part furnish a copy of the completed ‘‘No- from any poultry carcass or part there- tice of Detention’’ to the owner, or the of; or any dead, dying, disabled, or dis- owner’s agent. Such copy shall be eased poultry is subject to detention served, as soon as possible, by deliv- for a period not to exceed 20 days when ering the notification to the owner, or found by any authorized representative of the Secretary upon any premises the owner’s agent, or by certifying and where it is held for purposes of, or dur- mailing the notification to the owner, ing or after distribution in commerce or the owner’s agent, at his or her last or otherwise subject to the Act, and known residence or principal office or there is reason to believe that any such place of business. poultry or other article is adulterated [55 FR 47843, Nov. 16, 1990] or misbranded and is capable of use as human food or has not been inspected, in violation of the provisions of the

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§ 381.213 Notification of governmental the representative that the article is authorities having jurisdiction over eligible to retain such marks. article detained; form of written notification. [37 FR 9706, May 16, 1972, as amended at 55 FR 47843, Nov. 16, 1990] Within 48 hours after the detention of any poultry or other article pursuant § 381.215 Poultry or other articles sub- to § 381.211, an authorized representa- ject to judicial seizure and con- tive of the Secretary shall give oral or demnation. written notification of such detention Any poultry carcass, or part thereof, to any Federal authorities not con- or any product made wholly or in part nected with the Inspection Service, and from any poultry carcass or part there- any State or other governmental au- of; except those exempted from the def- thorities, having jurisdiction over such inition of a poultry product in § 381.15, article. In the event notification is or any dead, dying, disabled, or dis- given orally, it shall be confirmed in eased poultry, that is being trans- writing, as promptly as circumstances ported in commerce or is otherwise permit. subject to the Act, or is held for sale in the United States after such transpor- § 381.214 Movement of poultry or other tation, is subject to seizure and con- article detained; removal of official demnation, in a judicial proceeding marks. pursuant to section 20 of the Act if (a) No poultry or other article de- such poultry or other article: tained in accordance with the provi- (a) Is or has been processed, sold, sions in this subpart shall be moved by transported, or otherwise distributed any person from the place at which it or offered or received for distribution is located when so detained, until rein violation of the Act; or leased by an authorized representative (b) Is capable of use as human food of the Secretary: Provided, That any and is adulterated or misbranded; or such article may be moved from the (c) In any other way is in violation of place at which it is located when so de- the Act. tained, for refrigeration or freezing, or storage purposes if such movement has § 381.216 Procedure for judicial sei- been approved by an authorized rep- zure, condemnation, and disposi- resentative of the Secretary and the tion. article so moved will be further de- Any poultry or other article subject tained by an authorized representative to seizure and condemnation under this of the Secretary after such movement. subpart is liable to be proceeded (b) Upon terminating the detention against and seized and condemned, and of such article, an authorized rep- disposed of, at any time, on an appro- resentative of the Secretary shall: priate pleading in any U.S. district (1) Orally notify the immediate cus- court, or other proper court specified todian of the released article, and in section 21 of the Act, within the ju- (2) Furnish copies of a completed risdiction of which the article is found. ‘‘Notice of Termination of Detention’’ (FSIS Form 8400–1) to the persons noti- § 381.217 Authority for condemnation fied when the article was detained. The or seizure under other provisions of notice shall be served by either deliv- law. ering the notice to such persons or by The provisions of this subpart relat- certifying and mailing the notice to ing to detention, seizure, condemna- such persons at their last known resi- tion and disposition of poultry or other dences or principal offices or places of articles do not derogate from authority business. for retention, condemnation, or seizure (c) All official marks may be required conferred by other provisions of the by such representative to be removed Act, or other laws. from such article before it is released unless it appears to the satisfaction of

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§ 381.218 Criminal offenses. Effective date of application of The Act contains criminal provisions States Federal provi- with respect to numerous offenses spec- sions ified in the Act, including but not lim- New Jersey ...... Do. ited to forcible assaults on, or other in- New Mexico ...... Aug. 13, 2007. terference with, any person while en- New York ...... Apr. 10, 1977. gaged in, or on account of the perform- Northern Mariana Islands ...... Oct. 29, 1979. Oregon ...... Jan. 2, 1971. ance of, his official duties under the Pennsylvania ...... Oct. 31, 1971. Act. Criminal provisions with respect Puerto Rico ...... Jan. 17, 1972. to gifts or offers of bribes to such per- Rhode Island ...... Oct. 1, 1981. sons and related offenses are contained South Dakota ...... Jan. 2, 1971. in the general criminal code (18 U.S.C. Tennessee ...... Oct. 1, 1975. Virgin Islands ...... Nov. 27, 1971. 201). Washington ...... June 1, 1973.

Subpart V—Special Provisions for [42 FR 2949, Jan. 14, 1977] Designated States and Terri- EDITORIAL NOTE: For FEDERAL REGISTER ci- tories; Criteria and Procedure tations affecting § 381.221, see the List of CFR for Designating Establishments Sections Affected, which appears in the With Operations Which Would Finding Aids section of the printed volume Clearly Endanger the Public and at www.fdsys.gov. Health; Disposition of Poultry § 381.222 States designated under Products Therein paragraph 5(c) of the Act; application of regulations. § 381.220 Definition of ‘‘State’’. The provisions of the regulations in For purposes of this subpart, the this part apply to operations and trans- term ‘‘State’’ means any State (includ- actions wholly within each State des- ing the Commonwealth of Puerto Rico) ignated in § 381.221 under paragraph 5(c) or organized territory. of the Act, except as otherwise provided in this section. (The provisions of § 381.221 Designation of States under paragraph 5(c) of the Act. the regulations apply in all respects to operations and transactions in or for Each of the following States has been commerce.) designated, under paragraph 5(c) of the (a) Each establishment located in Act, as a State in which the provisions such a designated State, shall be grant- of sections 1 through 4, 6 through 10, ed inspection required under § 381.6(b) and 12 through 22 of the Act shall apply only if it is found, upon a combined to operations and transactions wholly evaluation of its premises, facilities, within the State. The Federal provi- and operating procedures, to be capable sions apply, effective on the dates of producing products that are not shown below: adulterated or misbranded. Effective date of (b) Section 381.26 will apply to estab- application of lishments required to have inspection States Federal provisions under § 381.6(b), except that existing interconnections between official and Alaska ...... July 31, 1999. unofficial establishments or between Arkansas ...... Jan. 2, 1971. California ...... Apr. 1, 1976. official establishments will be per- Colorado ...... Jan. 2, 1971. mitted if it is determined in specific Connecticut ...... Oct. 1, 1975. cases that the interconnections are Florida ...... Dec. 2, 1997. Georgia ...... Jan. 2, 1971. such that transfer of inedible poultry Guam ...... Jan. 21, 1972. product into the official establishment Hawaii ...... Nov. 1, 1995. would be difficult or unusual, and any Idaho ...... Jan. 2, 1971. such transfers are strictly prohibited, Kentucky ...... July 28, 1971. Maryland ...... Mar. 31, 1991. except as permitted under other provi- Massachusetts ...... Jan. 12, 1976. sions of the regulations. It is essential Michigan ...... Jan. 2, 1971. that separation of facilities be main- Nebraska ...... July 28, 1971. Nevada ...... July 1, 1973. tained to the extent necessary to as- New Hampshire ...... Aug. 6, 1978 sure that inedible poultry product does

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not enter the official establishment Front Line Supervisor) to the FSIS La- contrary to the regulations. beling and Program Delivery Staff at (c) Sections 381.49 and 381.51 shall headquarters, accompanied by the for- apply to such establishments, except mula and details of preparation and that separate facilities for men and packaging for each product. Within 90 women workers will not be required days after inauguration of inspection, when the majority of the workers in all labeling material and marking de- the establishment are related by blood vices temporarily approved by the or marriage, provided that this will not Front Line Supervisor must receive ap- conflict with municipal or State re- proval as required by § 412.1 or their use quirements; and except that separation must be discontinued. of toilet soil lines from house drainage (4) The Front Line Supervisor will lines to a point outside the buildings also review all shipping containers to will not be required in existing con- ensure that they do not have any false struction when positive acting back- or misleading labeling and are other- flow devices are installed. wise not misbranded. Modifications of (d) Subpart N of this part shall apply unacceptable information on labeling to such establishments except as pro- material by the use of pressure sen- vided in this paragraph (d). sitive tape of a type that cannot be re- (1) The operator of each such estab- moved without visible evidence of such lishment shall, prior to the inaugura- removal, or by blocking out with an tion of inspection, identify all labeling ink stamp will be authorized on a tem- and marking devices in use, or pro- porary basis to permit the maximum posed for use (upon the date of inau- allowable use of all labeling materials guration of inspection) to the Front on hand. All unacceptable labeling ma- Line Supervisor in which the establish- terial which is not modified to comply ment is located. Temporary approval, with the requirements of the regula- pending formal approval under § 412.1 of tions must be destroyed or removed this chapter, will be granted by the from the official establishment. Front Line Supervisor for labeling and (e) Sections 381.175 through 381.179 marking devices that he determines apply to operations and transactions are neither false nor misleading, pro- not in or for commerce in a State des- vided the official inspection legend ignated under paragraph 5(c) only if bearing the official establishment the State is also designated under sec- number is applied to the principal dis- tion 11 of the Act and if such provisions play panel of each label, either by a are applicable as shown in § 381.224. mechanical printing device or a self-de- structive pressure sensitive sticker, (f) Section 381.185(a) will not apply to and provided the label shows the true States designated under paragraph 5(c) product name, an accurate ingredient of the Act. statement, the name and address of the (g) Provisions of this part relating to manufacturer, packer, or distributor, exports and imports do not apply to op- and any other features required by sec- erations and transactions solely in or tion 4(h) of the Act. for intrastate commerce. (2) The Front Line Supervisor will [37 FR 9706, May 16, 1972, as amended at 39 forward one copy of each item of label- FR 4569, Feb. 5, 1974; 62 FR 45027, Aug. 25, ing and a description of each marking 1997; 78 FR 66838, Nov. 7, 2013] device for which he has granted temporary approval to the FSIS Labeling § 381.223 Control and disposition of and Program Delivery Staff and will nonfederally inspected poultry retain one copy in a temporary ap- products in States designated proval file for the establishment. under paragraph 5(c) of the Act. (3) The operator of the official estab- Upon the effective date of designa- lishment shall promptly forward a copy tion of a State under paragraph 5(c) of of each item of labeling and a descrip- the Act, no poultry products can be tion of each marking device for which processed within the State unless they temporary approval has been granted are prepared under inspection pursuant by the Front Line Supervisor (showing to the regulations or are exempted any modifications required by the from the requirement of inspection

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under § 381.10, and no unexempted poul- products may be distributed within the try products which were processed designated State, except as provided in without any inspection can lawfully be § 381.10. distributed within the State. For a period of 90 days from the effective date § 381.224 Designation of States under of such designation, poultry products section 11 of the Act; application of which were processed in any State list- sections of the Act and the regula- ed in § 381.187 and inspected and passed tions. under the supervision of a responsible Each of the following States has been State or local inspection agency or ex- designated, effective on the date shown empted from State inspection can be below, under section 11 of the Act, as a distributed solely within the State, State in which the provisions of the provided they are not adulterated or sections of the Act and regulations misbranded, except that the official in- specified below shall apply to operators spection legend shall not be used. Such engaged, other than in or for com- products may not enter official establishments. After said 90-day period, merce, in the kinds of business indi- only federally inspected and passed cated below:

Paragraphs of act and regulations Classes of operators State Effective date

Act, 11(b): §§ 381.175– Persons engaged (not in or for commerce) in (1) the busi- Alaska ...... July 31, 1999. 381.178. ness of slaughtering any poultry or processing, freezing, Arkansas ...... Apr. 1, 1976. packaging, or labeling any poultry carcasses, or parts or California ...... July 1, 1975. products thereof, for use as human food or animal food; Colorado ...... Oct. 1, 1975. (2) the business of buying or selling (as a poultry products Connecticut ...... Nov. 12, 1976. broker, wholesaler, or otherwise), transporting or storing Georgia ...... Nov. 19, 1976. any poultry carcasses, or parts or products thereof; or (3) Guam ...... Nov. 12, 1976. business as a renderer or in the business of buying, sell- Idaho ...... Apr. 18, 1973. ing, or transporting any dead, dying, disabled, or diseased Kentucky ...... Nov. 12, 1976. poultry or parts of carcasses of any poultry that died other- Maryland ...... Jan. 12, 1976. wise than by slaughter. Massachusetts ... Nov. 12, 1976. Michigan ...... Jan. 31, 1975. Nebraska ...... Jan. 31, 1975. Nevada ...... Oct. 29, 1979. New Hampshire .. July 1, 1975. New Jersey ...... July 16, 1975. New York ...... July 23, 1973. Northern Mariana Oct. 29, 1979. Islands. Jan. 31, 1975. Oregon ...... Pennsylvania ...... May 2, 1974. Puerto Rico ...... Nov. 19, 1976. Rhode Island ...... Mar. 29, 1982. South Dakota ..... Nov. 12, 1976. Tennessee ...... Oct. 1, 1975. Virgin Islands ...... Nov. 19, 1976. Washington ...... Jan. 31, 1975. Nov. 12, 1976.

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Paragraphs of act and regulations Classes of operators State Effective date

Act, 11(c); § 381.179 ...... Persons engaged (not in or for commerce) in business as a Alaska ...... July 31, 1999. poultry products broker; renderer; animal food manufac- Arkansas ...... Apr. 1, 1976. turer; wholesaler or public warehouseman of poultry car- California ...... July 1, 1975. casses, or parts or products thereof; or buying, selling, or Colorado ...... Oct. 1, 1975. transporting dead, dying, disabled, or diseased poultry or Connecticut ...... Nov. 12, 1976. parts of carcasses of any poultry that died otherwise than Georgia ...... Nov. 19, 1976. by slaughter. Guam ...... Nov. 12, 1976. Idaho ...... Apr. 18, 1973. Kentucky ...... Nov. 12, 1976. Maryland ...... Jan. 12, 1976. Massachusetts ... Nov. 12, 1976. Michigan ...... Jan. 31, 1975. Nebraska ...... Jan. 31, 1975. Nevada ...... Oct. 29, 1979. New Hampshire .. July 1, 1975. New Jersey ...... July 16, 1975. New York ...... July 23, 1973. Northern Mariana Oct. 29, 1979. Islands. Jan. 31, 1975. Oregon ...... Pennsylvania ...... May 2, 1974. Puerto Rico ...... Nov. 19, 1976. Rhode Island ...... Mar. 29, 1982. South Dakota ..... Nov. 12, 1976. Tennessee ...... Oct. 1, 1975. Virgin Islands ...... Nov. 19, 1976. Washington ...... Jan. 31, 1975. Nov. 12, 1976. Act, 11(d); 381.194 ...... Persons engaged (not in or for commerce) in the business of Alaska ...... July 31, 1999. buying, selling or transporting any dead, dying, disabled or Arkansas ...... Nov. 12, 1976. diseased poultry, or parts or carcasses of any poultry that Georgia ...... Nov. 19, 1976. died otherwise than by slaughter. Guam ...... Nov. 12, 1976. Idaho ...... Nov. 12, 1976. Maryland ...... Nov. 12, 1976. Michigan ...... Oct. 29, 1979. New Hampshire .. Oct. 29, 1979. Northern Mariana Nov. 19, 1976. Islands. Puerto Rico ...... Mar. 29, 1982. Rhode Island ...... Nov. 12, 1976. South Dakota ..... Nov. 19, 1976. Virgin Islands ...... Nov. 12, 1976.

[37 FR 9706, May 16, 1972; 65 FR 6888, Feb. 11, 2000]

EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 381.224, see the List of CFR Sections Affected, which appears in the Finding Aids section of the printed volume and at www.fdsys.gov.

§ 381.225 Criteria and procedure for (1) Any poultry product processed at designating establishments with op- the establishment is adulterated in any erations which would clearly en- of the following respects: danger the public health; disposi- (i) It bears or contains a pesticide tion of poultry products therein. chemical, food additive, or color addi- (a) An establishment in any State tive, that is ‘‘unsafe’’ within the mean- not listed in § 381.221 that is preparing ing of section 408, 409, or 706 of the Fed- poultry products solely for distribution eral Food, Drug, and Cosmetic Act or within such State shall be designated was intentionally subjected to radi- as one producing adulterated products ation in a manner not permitted under which would clearly endanger the pub- section 409 of said Act; or if it bears or lic health, if: contains any other added poisonous or

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added deleterious substance which may propriate Advisory Committee, for ef- render it injurious to health or make it fective action under State or local law unfit for human food; or to prevent such endangering of the (ii) It consists in whole or in part of public health. Such written notifica- any filthy, putrid or decomposed sub- tion shall clearly specify the defi- stance or is for any other reason un- ciencies deemed to result in the pro- sound, unhealthful, unwholesome, or duction of adulterated poultry prod- otherwise unfit for human food (for ex- ucts and shall specify a reasonable ample, it was prepared from a poultry time for such action under State or carcass or other ingredients exhibiting local law. spoilage characteristics); or it is, or (2) If effective action is not taken was prepared from, a poultry carcass under State or local law within the which would be required to be con- specified time, written notification demned under subpart K at official es- shall be issued by the Regional Direc- tablishments; or tor to the operator of the establish- (iii) It has been prepared, packed or ment, specifying the deficiencies in- held under insanitary conditions volved and allowing him 10 days to whereby it may have become contami- present his views or make the nec- nated with filth or may have been ren- essary corrections, and notifying him dered injurious to health (for example, that failure to correct such deficiencies if insects or vermin are not effectively may result in designation of the estab- controlled at the establishment, or in- lishment and operator thereof as sub- sanitary water is used in preparing ject to the provisions of sections 1 poultry products for human food); or through 4, 6 through 10, and 12 through (iv) It is, in whole or in part, the 22 of the Act as though engaged in product of poultry that died otherwise commerce. than by slaughter; or (3) Thereafter the inspector shall sur- (v) Its container is composed, in vey the establishment and designate it whole or in part, of any poisonous or if he determines, in consultation with deleterious substance which may the Regional Director, that it is pro- render the contents injurious to ducing adulterated poultry products, health; and which would clearly endanger the pub- (2) Such adulterated articles are in- lic health, and formal notice of such tended to be or are distributed from designation will be issued to the oper- the establishment while capable of use ator of the establishment by the Re- as human food. gional Director. (b) When any such establishment is (c) Poultry products on hand at the identified by an inspector as one pro- time of designation of an establish- ducing adulterated poultry products ment under this section are subject to which would clearly endanger public retention or detention, and seizure and health under the criteria in paragraph condemnation in accordance with (a) of this section, the following proce- § 381.145 or subpart U of this part: Pro- dure will be followed: vided, That poultry products that have (1) The inspector will informally ad- been federally inspected and so identi- vise the operator of the establishment fied and that have not been further pre- concerning the deficiencies found by pared at any nonfederally inspected es- him and report his findings to the ap- tablishment may be released for dis- propriate Regional Director for the In- tribution if the products appear to be spection Service. When it is deter- not adulterated or misbranded at the mined by the Regional Director that time of such release. any establishment preparing poultry (d) No establishment designated products solely for distribution within under this section can lawfully prepare any State is producing adulterated any poultry products unless it first ob- poultry products for distribution with- tains inspection or qualifies for exemp- in such State which would clearly en- tion under § 381.10 of this subpart. All danger the public health, written noti- other provisions of the regulations fication thereof will be issued to the shall apply to establishments des- appropriate State officials, including ignated under this section to the same the Governor of the State and the ap- extent and in the same manner as if

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they were engaged in commerce, except ical factors are established by proc- that the exceptions provided for in essing authorities. § 381.222 shall apply to such establish- (i) Headspace. That portion of a con- ments. tainer not occupied by the product. (1) Gross headspace. The vertical dis- Subpart X—Canning and Canned tance between the level of the product Products (generally the liquid surface) in an up- right rigid container and the top edge SOURCE: 51 FR 45634, Dec. 19, 1986, unless of the container (i.e., the flange of an otherwise noted. unsealed can, the top of the double seam on a sealed can, or the top edge of § 381.300 Definitions. an unsealed jar). (a) Abnormal container. A container (2) Net headspace. The vertical dis- with any sign of swelling or product tance between the level of the product leakage or any evidence that the con- (generally the liquid surface) in an up- tents of the unopened container may be right rigid container and the inside spoiled. surface of the lid. (b) Acidified low acid product. A canned product which has been formu- (j) Hermetically sealed containers. Air- lated or treated so that every compo- tight containers which are designed nent of the finished product has a pH of and intended to protect the contents 4.6 or lower within 24 hours after the against the entry of microorganisms completion of the thermal process un- during and after thermal processing. less data are available from the estab- (1) Rigid container. A container, the lishment’s processing authority dem- shape or contour of which, when filled onstrating that a longer time period is and sealed, is neither affected by the safe. enclosed product nor deformed by ex- (c) Bleeders. Small orifices on a retort ternal mechanical pressure of up to 10 through which steam, other gasses, and pounds per square inch gauge (0.7 kg/ condensate are emitted from the retort cm2) (i.e., normal firm finger pressure). throughout the entire thermal process. (2) Semirigid container. A container, (d) Canned product. A poultry food the shape or contour of which, when product with a water activity above filled and sealed, is not significantly 0.85 which receives a thermal process affected by the enclosed product under either before or after being packed in a hermetically sealed container. Unless normal atmospheric temperature and otherwise specified, the term ‘‘prod- pressure, but can be deformed by exter- uct’’ as used in this subpart G shall nal mechanical pressure of less than 10 mean ‘‘canned product.’’ pounds per square inch gauge (0.7 kg/ (e) Closure technician. The indi- cm2) (i.e., normal firm finger pressure). vidual(s) identified by the establish- (3) Flexible container. A container, the ment as being trained to perform spe- shape or contour of which, when filled cific container integrity examinations and sealed, is significantly affected by as required by this subpart and des- the enclosed product. ignated by the establishment to per- (k) Incubation tests. Tests in which form such examinations. the thermally processed product is (f) Code lot. All production of a par- kept at a specific temperature for a ticular product in a specific size con- specified period of time in order to de- tainer marked with a specific con- termine if outgrowth of microorga- tainer code. nisms occurs. (g) Come-up time. The elapsed time, (l) Initial temperature. The tempera- including venting time (if applicable), between the introduction of the heat- ture, determined at the initiation of a ing medium into a closed retort and thermal process cycle, of the contents the start of process timing. of the coldest container to be proc- (h) Critical factor. Any characteristic, essed. condition or aspect of a product, con- (m) Low acid product. A canned prod- tainer, or procedure that affects the uct in which any component has a pH adequacy of the process schedule. Crit- value above 4.6.

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(n) Process schedule. The thermal (w) Venting. The removal of air from process and any specified critical fac- a retort before the start of process tim- tors for a given canned product re- ing. quired to achieve shelf stability. (x) Water activity. The ratio of the (o) Process temperature. The minimum water vapor pressure of the product to temperature(s) of the heating medium the vapor pressure of pure water at the to be maintained as specified in the same temperature. process schedule. § 381.301 Containers and closures. (p) Process time. The intended time(s) a container is to be exposed to the (a) Examination and cleaning of empty heating medium while the heating me- containers. (1) Empty containers, clo- dium is at or above the process tem- sures, and flexible pouch roll stock shall be evaluated by the establish- perature(s). ment to ensure that they are clean and (q) Processing authority. The person(s) free of structural defects and damage or organization(s) having expert knowl- that may affect product or container edge of thermal processing require- integrity. Such an examination should ments for foods in hermetically sealed be based upon a statistical sampling containers, having access to facilities plan. for making such determinations, and (2) All empty containers, closures, designated by the establishment to per- and flexible pouch roll stock shall be form certain functions as indicated in stored, handled, and conveyed in such a this subpart. manner that will prevent soiling and (r) Program employee. Any inspector damage that could affect the hermetic or other individual employed by the condition of the sealed container. Department or any cooperating agency (3) Just before filling, rigid con- who is authorized by the Secretary to tainers shall be cleaned to prevent in- do any work or perform any duty in corporation of foreign matter into the connection with the Program (see finished product. Closures, semirigid § 301.2(f)). containers, preformed flexible pouches, (s) Retort. A pressure vessel designed and flexible pouch roll stock contained for thermal processing of product in original wrappings do not need to be packed in hermetically sealed con- cleaned before use. tainers. (b) Closure examinations for rigid con- (t) Seals. Those parts of a semirigid tainers (cans). (1) Visual examinations. container and lid or of a flexible con- A closure technician shall visually ex- tainer that are fused together in order amine the double seams formed by to hermetically close the container. each closing machine head. When seam (u) Shelf stability. The condition defects (e.g., cutovers, sharpness, achieved by application of heat, suffi- knocked down flanges, false seams, cient, alone or in combination with droops) are observed, necessary corrective actions, such as adjusting or re- other ingredients and/or treatments, to pairing the closing machine, shall be render the product free of microorga- taken. In addition to the double seams, nisms capable of growing in the prod- the entire container shall be examined uct at nonrefrigerated conditions (over for product leakage or obvious defects. 50 °F or 10 °C) at which the product is A visual examination shall be per- intended to be held during distribution formed on at least one container from and storage. Shelf stability and shelf each closing machine head, and the ob- stable are synonymous with commer- servations, along with any corrective cial sterility and commercially sterile, actions, shall be recorded. Visual ex- respectively. aminations shall be recorded. Visual (v) Thermal process. The heat treat- examinations shall be conducted with ment necessary to achieve shelf sta- sufficient frequency to ensure proper bility as determined by the establish- closure and should be conducted at ment’s processing authority. It is least every 30 minutes of continuous quantified in terms of: closing machine operation. Additional (1) Time(s) and temperature(s); or visual examinations shall be made by (2) Minimum product temperature. the closure technician at the beginning

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of production, immediately following (4) Cover hook length—CH. every jam in the closing machine and Maximum and minimum values for after closing machine adjustment (in- each dimensional measurement shall cluding adjustment for changes in con- be recorded by the closure technician. tainer size). (2) Teardown examinations. Teardown examinations of double seams formed by each closing machine head shall be performed by a closure technician at a frequency sufficient to ensure proper closure. These examinations should be made at intervals of not more than 4 hours of continuous closing machine operation. At least one container from each closing head shall be examined on the packer’s end during each regular examination period. Examination results along with any necessary corrective actions, such as adjusting or repairing the closing machine, shall be promptly recorded by the closure technician. The establishment shall have container specification guidelines for double seam integrity on file and available for review by Program employees. A teardown examination of the can maker’s end shall be performed on at least one container selected from each (b) Seamscope or seam projector. Re- closing machine during each examina- quired measurements of the seam in- tion period except when teardown exclude thickness, body hook, and over- aminations are made on incoming lap. Seam thickness shall be obtained empty containers or when, in the case by micrometer. For cylindrical con- of self-manufactured containers, the tainers, at least two locations, exclud- containers are made in the vicinity of ing the side seam juncture, shall be the establishment and the container used to obtain the required measure- plant records are made available to ments. Program employees. Additional tear- (ii) Seam tightness. Regardless of the down examinations on the packer’s end dimensional measurement method used should be made at the beginning of pro- to measure seam dimensions, at a min- duction, immediately following every imum, the seam(s) examined shall be jam in a closing machine and after stripped to assess the degree of wrin- closing machine adjustment (including kling. adjustment for a change in container (iii) Side seam juncture rating. Regard- size). The following procedures shall be less of the dimensional measurement used in teardown examinations of dou- method used to measure seam dimen- ble seams: sions, the cover hook shall be stripped (i) One of the following two methods shall be employed for dimensional to examine the cover hook droop at the measurements of the double seam. juncture for containers having side (a) Micrometer measurement. For cylin- seams. drical containers, measure the fol- (iv) Examination of noncylindrical con- lowing dimensions (Figure 1) at three tainers. Examination of noncylindrical points approximately 120 degrees apart containers (e.g., square, rectangular, on the double seam excluding and at ‘‘D’’-shaped, and irregularly-shaped) least one-half inch from the side seam shall be conducted as described in para- juncture: graphs (b)(2) (i), (ii), and (iii) of this (1) Double seam length—W; section except that the required dimen- (2) Double seam thickness—S; sional measurements shall be made on (3) Body hook length—BH; and the double seam at the points listed in

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the establishment’s container speci- formed by each sealing machine. When fication guidelines. sealing defects are observed, necessary (c) Closure examinations for glass con- corrective actions, such as adjusting or tainers—(1) Visual examinations. A clo- repairing the sealing machine, shall be sure technician shall visually assess taken and recorded. In addition to ex- the adequacy of the closures formed by amining the heat seals, the entire con- each closing machine. When closure de- tainer shall be examined for product fects, such as loose or cocked caps, leakage or obvious defects. Visual ex- fractured or cracked containers and aminations shall be performed before low vacuum jars, are observed, nec- and after the thermal processing oper- essary corrective actions, such as ad- ation with sufficient frequency to en- justing or repairing the closing ma- sure proper closure. These examina- chine, shall be taken and recorded. In tions should be conducted at least in addition to the closures, the entire accordance with a statistical sampling container shall be examined for de- plan. All defects noted and corrective fects. Visual examinations shall be actions taken shall be promptly re- made with sufficient frequency to en- corded. sure proper closure and should be conducted at least every 30 minutes of con- (ii) Physical tests. Tests determined tinuous closing machine operation. Ad- by the establishment as necessary to ditional visual examinations shall be assess container integrity shall be con- made by the closure technician and the ducted by the closure technician at a observations recorded at the beginning frequency sufficient to ensure proper of production, immediately following closure. These tests shall be performed every jam in the closing machine, and after the thermal processing operation after closing machine adjustment (in- and should be made at least every 2 cluding adjustment for a change in hours of continuous production. The container size). establishment’s acceptance guidelines (2) Closure examinations and tests. De- for each test procedure shall be on file pending upon the container and clo- and available for review by Program sure, tests shall be performed by a clo- employees. Test results along with any sure technician at a frequency suffi- necessary corrective actions, such as cient to ensure proper closure. These adjusting or repairing the sealing ma- examinations should be made either chine, shall be recorded. before or after thermal processing and (2) Double seams on semirigid or at intervals of not more than 4 hours of flexible containers shall be examined continuous closing machine operation. and the results recorded as provided in At least one container from each clos- paragraph (b) of this section. Any addi- ing machine shall be examined during tional measurements specified by the each regular examination period. Ex- container manufacturer shall also be amination results along with any nec- made and recorded. essary corrective actions, such as ad- (e) Container coding. Each container justing or repairing the closing ma- shall be marked with a permanent, leg- chine, shall be promptly recorded by the closure technician. The establish- ible, identifying code mark. The mark ment shall have specification guide- shall, at a minimum, identify in code lines for closure integrity on file and the product (unless the product name available for review by Program em- is lithographed or printed elsewhere on ployees. Additional closure examina- the container) and the day and year tions should be made at the beginning the product was packed. of production, immediately following (f) Handling of containers after closure. every jam in the closing machine and (1) Containers and closures shall be after closing machine adjustment (in- protected from damage which may cluding adjustment for a change in cause defects that are likely to affect container size). the hermetic condition of the con- (d) Closure examinations for semirigid tainers. The accumulation of sta- and flexible containers—(1) Heat seals— tionary containers on moving con- (i) Visual examinations. A closure tech- veyors should be minimized to avoid nician shall visually examine the seals damage to the containers.

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(2) The maximum time lapse between tablishment. Upon request by Program closing and initiation of thermal proc- employees, the establishment shall essing shall be 2 hours. However, the make available such letters or written Administrator may specify a shorter communications (or copies thereof). If period of time when considered nec- critical factors are identified in the essary to ensure product safety and process schedule, the establishment stability. A longer period of time be- shall provide the inspector with a copy tween closing and the initiation of of the procedures for measuring, con- thermal processing may be permitted trolling, and recording these factors, by the Administrator. along with the frequency of such meas- (Approved by the Office of Management and urements, to ensure that the critical Budget under control number 0583–0015) factors remain within the limits used to establish the process schedule. Once § 381.302 Thermal processing. submitted, the process schedules and (a) Process schedules. Prior to the associated critical factors and the pro- processing of canned product for dis- cedures for measuring (including the tribution in commerce, an establish- frequency), controlling, and recording ment shall have a process schedule (as of critical factors shall not be changed defined in § 381.300(n) of this subpart) without the prior written submittal of for each canned poultry product to be the revised procedures (including sup- packed by the establishment. porting documentation) to the inspec- (b) Source of process schedules. (1) tor at the establishment. Process schedules used by an establish- (Approved by the Office of Management and ment shall be developed or determined Budget under control number 0583–0015) by a processing authority. (2) Any change in product formula- § 381.303 Critical factors and the appli- tion, ingredients, or treatments that cation of the process schedule. are not already incorporated in a proc- Critical factors specified in the process schedule and that may adversely af- ess schedule shall be measured, con- fect either the product heat penetra- trolled and recorded by the establish- tion profile or sterilization value re- ment to ensure that these factors requirements shall be evaluated by the main within the limits used to estab- establishment’s processing authority. lish the process schedule. Examples of If it is determined that any such factors that are often critical to proc- change adversely affects the adequacy ess schedule adequacy may include: of the process schedule, the processing (a) General. (1) Maximum fill-in authority shall amend the process weight or drained weight; schedule accordingly. (2) Arrangement of pieces in the con- (3) Complete records concerning all tainer; aspects of the development or determination of a process schedule, includ- (3) Container orientation during ther- ing any associated incubation tests, mal processing; shall be made available by the estab- (4) Product formulation; lishment to the Program employee (5) Particle size; upon request. (6) Maximum thickness for flexible, (c) Submittal of process information. (1) and to some extent semirigid con- Prior to the processing of canned prod- tainers during thermal processing; uct for distribution in commerce, the (7) Maximum pH; establishment shall provide the inspec- (8) Percent salt; tor at the establishment with a list of (9) Ingoing (or formulated) nitrite the process schedules (including alter- level (ppm); nate schedules) along with any addi- (10) Maximum water activity; and tional applicable information, such as (11) Product consistency or viscosity. the retort come-up operating proce- (b) Continuous rotary and batch agi- dures and critical factors. tating retorts. (1) Minimum headspace; (2) Letters or other written commu- and nications from a processing authority (2) Retort reel speed. recommending all process schedules (c) Hydrostatic retorts. (1) Chain or shall be maintained on file by the es- conveyor speed.

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(d) Steam/air retorts. (1) Steam/air eration functions or events, such as ratio; and process schedule time, come-up time (2) Heating medium flow rate. and retort venting, shall be accurate to (Approved by the Office of Management and assure that all such functions or events Budget under control number 0583–0015) are achieved. Pocket watches and wrist watches are not considered acceptable § 381.304 Operations in the thermal timing devices. Analog and digital processing area. clocks are considered acceptable. If (a) Posting of processes. Process sched- such clocks do not display seconds, all ules (or operating process schedules) required timed functions or events for daily production, including min- shall have at least a 1-minute safety imum initial temperatures and oper- factor over the specified thermal proc- ating procedures for thermal processing operation times. Temperature/ essing equipment, shall be posted in a time recording devices shall correspond conspicuous place near the thermal within 15 minutes to the time of the processing equipment. Alternatively, day recorded on written records re- such information shall be available to quired by § 381.306. the thermal processing system oper- (e) Measurement of pH. Unless other ator and the inspector. (b) Process indicators and retort traffic methods are approved by the Adminis- control. A system for product traffic trator, potentiometric methods using control shall be established to prevent electronic instruments (pH meters) product from bypassing the thermal shall be used for making pH determina- processing operation. Each basket, tions when a maximum pH value is crate or similar vehicle containing un- specified as a critical factor in a proc- processed product, or at least one visi- ess schedule. ble container in each vehicle, shall be plainly and conspicuously marked with § 381.305 Equipment and procedures a heat sensitive indicator that will vis- for heat processing systems. ually indicate whether such unit has (a) Instruments and controls common to been thermally processed. Exposed different thermal processing systems—(1) heat sensitive indicators attached to Indicating temperature devices. Each re- container vehicles shall be removed be- tort shall be equipped with at least one fore such vehicles are refilled with un- indicating temperature device that processed product. Container loading measures the actual temperature with- systems for crateless retorts shall be in the retort. The indicating tempera- designed to prevent unprocessed prod- ture device, not the temperature/time uct from bypassing the thermal proc- recording device, shall be used as the essing operation. reference instrument for indicating the (c) Initial temperature. The initial process temperature. temperature of the contents of the (i) Mercury-in-glass thermometers. A coldest container to be processed shall mercury-in-glass thermometer shall be determined and recorded by the es- have divisions that are readable to 1 °F tablishment at the time the processing ° cycle begins to assure that the tem- (or 0.5 C) and whose scale contains not ° ° perature of the contents of every con- more than 17 F/inch (or 4.0 C/cm) of tainer to be processed is not lower than graduated scale. Each mercury-in-glass the minimum initial temperature spec- thermometer shall be tested for accu- ified in the process schedule. Thermal racy against a known accurate stand- processing systems which subject the ard upon installation and at least once filled and sealed containers to water at a year to ensure its accuracy. Records any time before process timing begins that specify the date, standard used, shall be operated to assure that such test method, and the person or testing water will not lower the temperature authority performing the test shall be of the product below the minimum ini- maintained on file by the establish- tial temperature specified in the proc- ment and made available to Program ess schedule. employees. A mercury-in-glass ther- (d) Timing devices. Devices used to mometer that has a divided mercury time applicable thermal processing op- column or that cannot be adjusted to

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the standard shall be repaired and test- lieu of chart-type devices must meet ed for accuracy before further use, or known accurate standards for such de- replaced. vices or procedures when tested for ac- (ii) Other devices. Temperature-indi- curacy. Such a device must be accurate cating devices used in lieu of mercury- enough for ensuring that process time in-glass thermometers, such as resist- and temperature parameters have been ance temperature detectors, shall meet met. known, accurate standards for such de- (3) Steam controllers. Each retort shall vices when tested for accuracy. The be equipped with an automatic steam records of such testing shall be avail- controller to maintain the retort tem- able to FSIS program employees. perature. This may be a recording/con- (2) Temperature/time recording devices. trolling instrument when combined Each thermal processing system shall with a temperature/time recording de- be equipped with at least one tempera- vice. ture/time recording device to provide a (4) Air valves. All air lines connected permanent record of temperatures to the retorts designed for pressure within the thermal processing system. processing in steam shall be equipped This recording device may be combined with a globe valve or other equivalent- with the steam controller and may be a type valve or piping arrangement that recording/controlling instrument. will prevent leakage of air into the re- When compared to the known accurate tort during the process cycle. indicating temperature device, the re- (5) Water valves. All retort water lines cording accuracy shall be equal to or that are intended to be closed during a better than 1 °F (or 0.5 °C) at the proc- process cycle shall be equipped with a ess temperature. The temperature re- globe valve or other equivalent-type cording chart should be adjusted to valve or piping arrangement that will agree with, but shall never be higher prevent leakage of water into the re- than, the known accurate indicating tort during the process cycle. temperature device. A means of preventing unauthorized changes in the (b) Pressure processing in steam—(1) adjustment shall be provided. For ex- Batch still retorts. (i) The basic require- ample, a lock or a notice from manage- ments and recommendations for indi- ment posted at or near the recording cating temperature devices and tem- device warning that only authorized perature/time recording devices are de- persons are permitted to make adjust- scribed in paragraphs (a) (1) and (2) of ments, are satisfactory means for pre- this section. Additionally, bulb sheaths venting unauthorized changes. Air-op- or probes of indicating temperature de- erated temperature controllers shall vices and probes of temperature/time have adequate filter systems to ensure recording devices shall be installed ei- a supply of clean, dry air. The recorder ther within the retort shell or in exter- timing mechanism shall be accurate. nal wells attached to the retort. Exter- (i) Chart-type devices. Devices using nal wells shall be connected to the re- charts shall be used only with the cor- tort through at least a 3⁄4 inch (1.9 cm) rect chart. Each chart shall have a diameter opening and equipped with a working scale of not more than 55 °F/ 1⁄16 inch (1.6 mm) or larger bleeder inch (or 12 °C/cm) within a range of 20 opening so located as to provide a con- °F (or 11 °C) of the process tempera- stant flow of steam past the length of ture. Chart graduations shall not ex- the bulb or probe. The bleeder for exceed 2 °F (or 1 °C) within a range of 10 ternal wells shall emit steam continu- °F (or 5 °C) of the process temperature. ously during the entire thermal proc- Multipoint plotting chart-type devices essing period. shall print temperature readings at in- (ii) Steam controllers are required as tervals that will assure that the pa- described in paragraph (a)(3) of this rameters of the process time and proc- section. ess temperature have been met. The (iii) Steam inlet. The steam inlet to frequency of recording should not ex- each retort shall be large enough to ceed 1-minute intervals. provide steam for proper operation of (ii) Other devices. Temperature/time the retort, and shall enter at a point to recording devices or procedures used in facilitate air removal during venting.

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(iv) Crate supports. Vertical still re- can observe that it is functioning prop- torts with bottom steam entry shall erly. The condensate bleeder shall be employ bottom retort crate supports. checked with sufficient frequency to Baffle plates shall not be used in the ensure adequate removal of conden- bottom of retorts. sate. Visual checks should be per- (v) Steam spreader. Perforated steam formed at intervals of not more than 15 spreaders, if used, shall be maintained minutes and the results recorded. to ensure they are not blocked or oth- Intermittent condensate removal sys- erwise inoperative. Horizontal still re- tems shall be equipped with an auto- torts shall be equipped with perforated matic alarm system that will serve as steam spreaders that extend the full a continuous monitor of condensate length of the retort unless the ade- bleeder functioning. The automatic quacy of another arrangement is docu- alarm system shall be tested at the be- mented by heat distribution data or ginning of each shift for proper func- other documentation from a processing tioning and the results recorded. If the authority. Such information shall be alarm system is not functioning prop- maintained on file by the establish- erly, it must be repaired before the re- ment and made available to Program tort is used. employees for review. (vii) Stacking equipment. (a) Equip- (vi) Bleeders and condensate removal. ment for holding or stacking con- Bleeders, except those for external tainers in retorts. Crates, trays, gon- wells of temperature devices, shall dolas, carts, and other vehicles for have 1⁄8 inch (or 3 mm) or larger open- holding or stacking product containers ings and shall be wide open during the in the retort shall be so constructed to entire process including the come-up ensure steam circulation during the time. For horizontal still retorts, venting, come-up, and process times. bleeders shall be located within ap- The bottom of each vehicle shall have proximately 1 foot (or 30 cm) of the perforations at least 1 inch (2.5 cm) in outermost locations of containers at diameter on 2 inch (or 5 cm) centers or each end along the top of the retort. the equivalent unless the adequacy of Additional bleeders shall be located another arrangement is documented by not more than 8 feet (2.4 m) apart along heat distribution data or other docu- the top. Bleeders may be installed at mentation from a processing authority positions other than those specified and such information is maintained on above, as long as the establishment has file by the establishment and made heat distribution data or other docu- available to Program employees for re- mentation from the manufacturer or view. from a processing authority dem- (b) Divider plates. Whenever one or onstrating that the bleeders accom- more divider plates are used between plish removal of air and circulate the any two layers of containers or placed steam within the retort. This informa- on the bottom of a retort vehicle, the tion shall be maintained on file by the establishment shall have on file docu- establishment and made available to mentation that the venting procedure Program employees for review. All allows the air to be removed from the bleeders shall be arranged in a way retort before timing of the thermal that enables the retort operator to ob- process is started. Such documentation serve that they are functioning prop- shall be in the form of heat distribu- erly. Vertical retorts shall have at tion data or documentation from a least one bleeder opening located in processing authority. This information the portion of the retort opposite the shall be made available to Program steam inlet. All bleeders shall be ar- employees for review. ranged so that the retort operator can (viii) Bleeder and vent mufflers. If muf- observe that they are functioning prop- flers are used on bleeders or vent sys- erly. In retorts having a steam inlet tems, the establishment shall have on above the level of the lowest container, file documentation that the mufflers a bleeder shall be installed in the bot- do not impede the removal of air from tom of the retort to remove conden- the retort. Such documentation shall sate. The condensate bleeder shall be consist of either heat distribution data so arranged that the retort operator or documentation from the muffler

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manufacturer or from a processing au- onstrates that the venting procedure thority. This information shall be used accomplishes the removal of air made available to Program employees and condensate. This information shall for review. be maintained on file by the establish- (ix) Vents. (a) Vents shall be located ment and made available to Program in that portion of the retort opposite employees for review. the steam inlet and shall be designed, (e) Examples of typical installations installed, and operated in such a way and operating procedures that comply that air is removed from the retort be- with the requirements of this section fore timing of the thermal process is are as follows: started. Vents shall be controlled by a (1) Venting horizontal retorts. gate, plug cock, or other full-flow valve (i) Venting through multiple 1 inch which shall be fully opened to permit (2.5 cm) vents discharging directly to rapid removal of air from retorts dur- the atmosphere. ing the venting period. (b) Vents shall not be connected to a closed drain system without an atmospheric break in the line. Where a retort manifold connects several pipes from a single retort, the manifold shall be controlled by a gate, plug cock, or other full-flow valve and the manifold shall be of a size such that the cross- sectional area of the manifold is larger than the total cross-sectional area of all connecting vents. The discharge shall not be connected to a closed drain Specifications (Figure 1): One, 1-inch (2.5 cm) without an atmospheric break in the vent for every 5 feet (1.5 m) of retort length, line. A manifold header connecting equipped with a gate, plug cock, or other full-flow valve and discharging to atmos- vents or manifolds from several still phere. The end vents shall not be more than retorts shall lead to the atmosphere. 21⁄2 feet (or 75 cm) from ends of retort. The manifold header shall not be con- Venting method (Figure 1): Vent valves shall trolled by a valve and shall be of a size be wide open for at least 5 minutes and to at such that the cross-sectional area is at least 225 °F (or 107 °C), or at least 7 minutes least equal to the total cross-sectional and to at least 220 °F (or 104.5 °C). area of all connecting retort manifold (ii) Venting through multiple 1 inch pipes from the maximum number of re- (2.5 cm) vents discharging through a torts to be vented simultaneously. manifold to the atmosphere. (c) Some typical installations and operating procedures are described below. Other retort installations, vent piping arrangements, operating procedures or auxiliary equipment such as divider plates may be used provided there is documentation that the air is removed from the retort before the process is started. Such documentation shall be in the form of heat distribution data or other documentation from the equipment manufacturer or processing authority. This information shall be Specifications (Figure 2): One, 1-inch (2.5 cm) maintained on file by the establish- vent for every 5 feet (1.5 m) of retort length; ment and made available to Program vents not over 21⁄2 feet (or 75 cm) from ends employees for review. of retort; size of manifold for retorts less 1 (d) For crateless retort installations, than 15 feet (4.6 m) in length, 2 ⁄2 inches (6.4 cm), and for retorts 15 feet (4.6 m) and over the establishment shall have heat dis- in length, 3 inches (7.6 cm). tribution data or other documentation Venting method (Figure 2): The manifold from the equipment manufacturer or vent gate, plug cock, or other full-flow valve from a processing authority that dem- shall be wide open for at least 6 minutes and

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to at least 225 °F (or 107 °C) or for at least 8 plug cock, or other full-flow valve and lo- minutes and to at least 220 °F (or 104.5 °C). cated within 2 feet (61 cm) of the center of (iii) Venting through water spreaders. the retort. Venting method (Figure 4): The vent valve shall be wide open for at least 4 minutes and to at least 220 °F (or 104.5 °C). (2) Venting vertical retorts. (i) Venting through a 11⁄2 inch (3.8 cm) overflow.

Specifications (Figure 3): Size of vent and vent valve. For retorts less than 15 feet (4.6 m) in length, 2 inches (or 5 cm); for retorts 15 feet (4.6 m) and over in length, 21⁄2 inches (6.4 cm). Size of water spreader (Figure 3): For retorts less than 15 feet (4.6 m) in length, 11⁄2 inches (3.8 cm); for retorts 15 feet (4.6 m) and over in length 2 inches (or 5 cm). The number of holes shall be such that their total cross-sectional area is equal to the cross-sectional area of the vent pipe inlet. Venting method (Figure 3): The gate, plug cock, or other full-flow valve on the water spreader vent shall be wide open for at least 5 minutes and to at least 225 °F (or 107 °C), or for at least 7 minutes and to at least 220 °F (or 104.5 °C).

(iv) Venting through a single 21⁄2 inch (6.4 cm) top vent for retorts not exceeding 15 feet (4.6 m) in length.

Specifications (Figure 5): A 11⁄2 inch (3.8 cm) overflow pipe equipped with a 11⁄2 inch (3.8 cm) gate, plug cock, or other full-flow valve and with not more than 6 feet (1.8 m) of 11⁄2 inch (3.8 cm) pipe beyond the valve before a break to the atmosphere or to a manifold header. Venting method (Figure 5): The vent valve shall be wide open for at least 4 minutes and to at least 218 °F (or 103.5 °C), or for at least 5 minutes and to at least 215 °F (or 101.5 °C).

Specifications (Figure 4): A 21⁄2 inch (6.4 cm) (ii) Venting through a single 1 inch vent equipped with a 21⁄2 inch (6.4 cm) gate, (2.5 cm) side or top vent.

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Specifications (Figure 6 or 7): A 1 inch (2.5 shall emit steam continuously during cm) vent in lid or top side, equipped with a the entire thermal processing period. gate, plug cock, or other full-flow valve and (ii) Steam controllers are required as discharging directly into the atmosphere or described in paragraph (a)(3) of this to a manifold header. section. Venting method (Figure 6 or 7): The vent valve shall be wide open for at least 5 min- (iii) Steam inlet. The steam inlet to utes and to at least 230 °F (110 °C), or for at each retort shall be large enough to least 7 minutes and to at least 220 °F (or 104.5 provide steam for proper operation of °C). the retort and shall enter at a point(s) to facilitate air removal during vent- (2) Batch agitating retorts. (i) The ing. basic requirements for indicating tem- (iv) Bleeders. Bleeders, except those perature devices and temperature/time for external wells of temperature de- recording devices are described in para- vices, shall be 1⁄8 inch (or 3 mm) or larg- graphs (a) (1) and (2) of this section. er and shall be wide open during the Additionally, bulb sheaths or probes of entire process including the come-up indicating temperature devices and time. Bleeders shall be located within probes of temperature/time recording approximately 1 foot (or 30 cm) of the devices shall be installed either within outermost location of containers, at the retort shell or in external wells at- each end along the top of the retort. tached to the retort. External wells Additional bleeders shall be located shall be connected to the retort not more than 8 feet (2.4 m) apart along through at least a 3⁄4 inch (1.9 cm) di- the top. Bleeders may be installed at ameter opening and equipped with a 1⁄16 positions other than those specified (1.6 mm) or larger bleeder opening so above, as long as the establishment has located as to provide a constant flow of heat distribution data or other docu- steam past the length of the bulbs or mentation from the manufacturer or probes. The bleeder for external wells from a processing authority that the

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bleeders accomplish removal of air and speed changes on retorts shall be pro- circulate the steam within the retort. vided. For example, a lock or a notice This information shall be maintained from management posted at or near on file by the establishment and made the speed adjustment device warning available to Program employees for re- that only authorized persons are per- view. All bleeders shall be arranged in mitted to make adjustments are satis- a way that enables the retort operator factory means of preventing unauthor- to observe that they are functioning ized changes. properly. (vii) Bleeder and vent mufflers. If muf- (v) Venting and condensate removal. flers are used on bleeders or vent sys- The air in the retort shall be removed tems, the establishment shall have doc- before processing is started. Heat dis- umentation that the mufflers do not tribution data or other documentation impede the removal of air from the re- from the manufacturer or from the tort. Such documentation shall consist processing authority who developed the of either heat distribution data or doc- venting procedure shall be kept on file umentation from the muffler manufac- by the establishment and made avail- turer or from a processing authority. able to Program employees for review. This information shall be maintained At the time the steam is turned on, the on file by the establishment and made drain shall be opened to remove steam available to Program employees for re- condensate from the retort. A bleeder view. shall be installed in the bottom of the (3) Continuous rotary retorts. (i) The retort to remove condensate during re- basic requirements for indicating tem- tort operation. The condensate bleeder perature devices and temperature/time shall be so arranged that the retort op- recording devices are described in para- erator can observe that it is func- graphs (a) (1) and (2) of this section. tioning properly. The condensate Additionally, bulb sheaths or probes of bleeder shall be checked with sufficient indicating temperature devices and frequency to ensure adequate removal probes of temperature/time recording of condensate. Visual checks should be devices shall be installed either within performed at intervals of not more the retort shell or in external wells at- than 15 minutes and the results re- tached to the retort. External wells corded. Intermittent condensate re- shall be connected to the retort moval systems shall be equipped with through at least a 3⁄4 inch (1.9 cm) dian automatic alarm system that will ameter opening and equipped with a 1⁄16 serve as a continuous monitor of con- inch (1.6 mm) or larger bleeder opening densate bleeder functioning. The auto- so located as to provide a constant flow matic alarm system shall be tested at of steam past the length of the bulbs or the beginning of each shift for proper probes. The bleeder for external wells functioning and the results recorded. If shall emit steam continuously during the alarm system is not functioning the entire thermal processing period. properly, it must be repaired before the (ii) Steam controllers are required as retort is used. described in paragraph (a)(3) of this (vi) Retort or reel speed timing. The re- section. tort or reel speed shall be checked be- (iii) Steam inlet. The steam inlet to fore process timing begins and, if need- each retort shall be large enough to ed, adjusted as specified in the process provide steam for proper operation of schedule. In addition, the rotational the retort, and shall enter at a point(s) speed shall be determined and recorded to facilitate air removal during vent- at least once during process timing of ing. each retort load processed. Alter- (iv) Bleeders. Bleeders, except those natively, a recording tachometer can for external wells of temperature de- be used to provide a continuous record vices, shall be 1⁄8 inch (3.2 mm) or larg- of the speed. The accuracy of the re- er and shall be wide open during the cording tachometer shall be deter- entire process, including the come-up mined and recorded at least once per time. Bleeders shall be located within shift by checking the retort or reel approximately 1 foot (or 30 cm) of the speed using an accurate stopwatch. A outermost location of containers at means of preventing unauthorized each end along the top of the retort.

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Additional bleeders shall be located speed is maintained. Alternatively, a not more than 8 feet (2.4 m) apart along recording tachometer may be used to the top of the retort. Bleeders may be provide a continuous record of the installed at positions other than those speed. If a recording tachometer is specified above, as long as the estab- used, the speed shall be manually lishment has heat distribution data or checked against an accurate stopwatch other documentation from the manu- at least once per shift and the results facturer or a processing authority that recorded. A means of preventing unau- the bleeders accomplish removal of air thorized speed changes on retorts shall and circulate the steam within the re- be provided. For example, a lock or a tort. This information shall be main- notice from management posted at or tained on file by the establishment and near the speed adjustment device warn- made available to Program employees ing that only authorized persons are for review. All bleeders shall be ar- permitted to make adjustments are ranged so that the retort operator can satisfactory means of preventing unau- observe that they are functioning prop- thorized changes. erly. (vii) Bleeders and vent mufflers. If muf- (v) Venting and condensate removal. flers are used on bleeders or vent sys- The air in the retort shall be removed tems, the establishment shall have doc- before processing is started. Heat dis- umentation that the mufflers do not tribution data or other documentation impede the removal of air from the re- from the manufacturer or from the tort. Such documentation shall consist processing authority who developed the of either heat distribution data or venting procedure shall be kept on file other documentation from the muffler by the establishment and made avail- manufacturer or from a processing au- able to Program employees for review. thority. This information shall be At the time the steam is turned on, the maintained on file by the establish- drain shall be opened to remove steam ment and made available to Program condensate from the retort. A bleeder employees for review. shall be installed in the bottom of the (4) Hydrostatic retorts. (i) The basic re- shell to remove condensate during the quirements for indicating temperature retort operation. The condensate bleed- devices and temperature/time recorder shall be so arranged that the retort ing devices are described in paragraphs operator can observe that it is func- (a) (1) and (2) of this section. Addition- tioning properly. The condensate ally, indicating temperature devices bleeder shall be checked with sufficient shall be located in the steam dome frequency to ensure adequate removal near the steam/water interface. Where of condensate. Visual checks should be the process schedule specifies mainte- performed at intervals of not more nance of particular water temperatures than 15 minutes and the results rein the hydrostatic water legs, at least corded. Intermittent condensate re- one indicating temperature device moval systems shall be equipped with shall be located in each hydrostatic an automatic alarm system that will water leg so that it can accurately serve as a continuous monitor of con- measure water temperature and be eas- densate bleeder functioning. The auto- ily read. The temperature/time re- matic alarm system shall be tested at corder probe shall be installed either the beginning of each shift for proper within the steam dome or in a well at- functioning and the results recorded. If tached to the dome. Each probe shall the alarm system is not functioning have a 1⁄16 inch (1.6 mm) or larger bleed- properly, it must be repaired before the er opening which emits steam continu- retort is used. ously during the processing period. Ad- (vi) Retort speed timing. The rota- ditional temperature/time recorder tional speed of the retort shall be spec- probes shall be installed in the hydro- ified in the process schedule. The speed static water legs if the process sched- shall be adjusted as specified, and re- ule specifies maintenance of particular corded by the establishment when the temperatures in these water legs. retort is started, and checked and re- (ii) Steam controllers are required as corded at intervals not to exceed 4 described in paragraph (a)(3) of this hours to ensure that the correct retort section.

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(iii) Steam inlet. The steam inlets ment and made available to Program shall be large enough to provide steam employees for review. for proper operation of the retort. (c) Pressure processing in water—(1) (iv) Bleeders. Bleeder openings 1⁄4 inch Batch still retorts. (i) The basic require- (or 6 mm) or larger shall be located in ments for indicating temperature de- the steam chamber(s) opposite the vices and temperature/time recording point of steam entry. Bleeders shall be devices are described in paragraphs wide open and shall emit steam con- (a)(1) and (2) of this section. Addition- tinuously during the entire process, in- ally, bulbs or probes of indicating tem- cluding the come-up time. All bleeders perature devices shall be located in shall be arranged in such a way that such a position that they are beneath the operator can observe that they are the surface of the water throughout functioning properly. the process. On horizontal retorts, the (v) Venting. Before the start of proc- indicating temperature device bulb or essing operations, the retort steam probe shall be inserted directly into chamber(s) shall be vented to ensure the retort shell. In both vertical and removal of air. Heat distribution data horizontal retorts, the indicating tem- or other documentation from the man- perature device bulb or probe shall ex- ufacturer or from a processing author- tend directly into the water a min- ity demonstrating that the air is re- imum of 2 inches (or 5 cm) without a moved from the retort prior to proc- separable well or sleeve. In vertical re- essing shall be kept on file at the es- torts equipped with a recorder/controller, the controller probe shall be lo- tablishment and made available to cated at the bottom of the retort below Program employees for review. the lowest crate rest in such a position (vi) The conveyor Conveyor speed. that the steam does not strike it di- speed shall be calculated to obtain the rectly. In horizontal retorts so required process time and recorded by equipped, the controller probe shall be the establishment when the retort is located between the water surface and started. The speed shall be checked and the horizontal plane passing through recorded at intervals not to exceed 4 the center of the retort so that there is hours to ensure that the correct con- no opportunity for direct steam im- veyor speed is maintained. A recording pingement on the controller probe. Air- device may be used to provide a contin- operated temperature controllers shall uous record of the conveyor speed. have filter systems to ensure a supply When a recording device is used, the of clean, dry air. speed shall be manually checked (ii) Pressure recording device. Each re- against an accurate stopwatch at least tort shall be equipped with a pressure once per shift by the establishment. A recording device which may be com- means of preventing unauthorized bined with a pressure controller. speed changes of the conveyor shall be (iii) Steam controllers are required provided. For example, a lock or a no- as described in paragraph (a)(3) of this tice from management posted at or section. near the speed adjustment device warn- (iv) Heat distribution. Heat distribu- ing that only authorized persons are tion data or other documentation from permitted to make adjustments are the equipment manufacturer or a proc- satisfactory means of preventing unau- essing authority demonstrating uni- thorized changes. form heat distribution within the re- (vii) Bleeders and vent mufflers. If muf- tort shall be kept on file at the estab- flers are used on bleeders or vent sys- lishment and made available to Pro- tems, the establishment shall have doc- gram employees for review. umentation that the mufflers do not (v) Crate supports. A bottom crate impede the removal of air from the re- support shall be used in vertical retort. Such documentation shall consist torts. Baffle plates shall not be used in of either heat distribution data or the bottom of the retort. other documentation from the muffler (vi) Stacking equipment. For filled manufacturer or from a processing au- flexible containers and, where applica- thority. This information shall be ble, semirigid containers, stacking maintained on file by the establish- equipment shall be designed to ensure

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that the thickness of the filled con- be maintained on file by the establish- tainers does not exceed that specified ment and made available to Program in the process schedule and that the employees for review. containers do not become displaced and (x) Water recirculation. When a water overlap or rest on one another during recirculation system is used for heat the thermal process. distribution, the water shall be drawn (vii) Drain valve. A nonclogging, from the bottom of the retort through water-tight drain valve shall be used. a suction manifold and discharged Screens shall be installed over all drain through a spreader that extends the openings. length or circumference of the top of (viii) Water level. There shall be a the retort. The holes in the water means of determining the water level spreader shall be uniformly distrib- in the retort during operation (i.e., by uted. The suction outlets shall be pro- using a gauge, electronic sensor, or tected with screens to keep debris from sight glass indicator). For retorts re- entering the recirculation system. The quiring complete immersion of containers, water shall cover the top layer pump shall be equipped with a pilot of containers during the entire come- light or a similar device to warn the up time and thermal processing periods operator when it is not running, and and should cover the top layer of con- with a bleeder to remove air when tainers during cooling. For retorts starting operations. Alternatively, a using cascading water or water sprays, flow-meter alarm system can be used the water level shall be maintained to ensure proper water circulation. The within the range specified by the retort adequacy of water circulation for manufacturer or processing authority maintaining uniform heat distribution during the entire come-up, thermal within the retort shall be documented processing, and cooling periods. A by heat distribution data or other doc- means to ensure that water circulation umentation from a processing author- continues as specified throughout the ity and such data shall be maintained come-up, thermal processing, and cool- on file by the establishment and made ing periods shall be provided. The re- available to Program employees for retort operator shall check and record view. Alternative methods for recir- the water level at intervals to ensure it culation of water in the retort may be meets the specified processing param- used, provided there is documentation eters. in the form of heat distribution data or (ix) Air supply and controls. In both other documentation from a processing horizontal and vertical still retorts, a authority maintained on file by the es- means shall be provided for introducing tablishment and made available to compressed air or steam at the pres- Program employees for review. sure required to maintain container in- (xi) Cooling water entry. In retorts for tegrity. Compressed air and steam processing product packed in glass jars, entry shall be controlled by an auto- the incoming cooling water should not matic pressure control unit. A non- directly strike the jars, in order to return valve shall be provided in the minimize glass breakage by thermal air supply line to prevent water from shock. entering the system. Overriding air or steam pressure shall be maintained (2) Batch agitating retorts. (i) The continuously during the come-up, ther- basic requirements and recommenda- mal processing, and cooling periods. If tions for indicating temperature de- air is used to promote circulation, it vices and temperture/time recording shall be introduced into the steam line devices are described in paragraphs (a) at a point between the retort and the (1) and (2) of this section. Additionally, steam control valve at the bottom of the indicating temperature device bulb the retort. The adequacy of the air cir- or probe shall extend directly into the culation for maintaining uniform heat water without a separable well or distribution within the retort shall be sleeve. The recorder/controller probe documented by heat distribution data shall be located between the water sur- or other documentation from a proc- face and the horizontal plane passing essing authority, and such data shall through the center of the retort so that

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there is no opportunity for steam to di- tort and the steam control valve at the rectly strike the controller bulb or bottom of the retort. The adequacy of probe. the air circulation for maintaining uni- (ii) Pressure recording device. Each reform heat distribution within the retort shall be equipped with a pressure tort shall be documented by heat dis- recording device which may be com- tribution data or other documentation bined with a pressure controller. from a processing authority, and such (iii) Steam controllers are required as data shall be maintained on file by the described in paragraph (a)(3) of this establishment and made available to section. Program employees for review. (iv) Heat distribution. Heat distribu- (ix) Retort or reel speed timing. The re- tion data or other documentation from tort or reel speed timing shall be the equipment manufacturer or a proc- checked before process timing begins essing authority shall be kept on file and, if needed, adjusted as specified in by the establishment and made avail- the process schedule. In addition, the able to Program employees for review. rotational speed shall be determined (v) Stacking equipment. All devices and recorded at least once during proc- used for holding product containers ess timing of each retort load proc- (e.g., crates, trays, divider plates) shall essed. Alternatively, a recording ta- be so constructed to allow the water to chometer can be used to provide a con- circulate around the containers during tinuous record of the speed. The accu- the come-up and thermal process peri- racy of the recording tachometer shall ods. be determined and recorded at least (vi) Drain valve. A nonclogging, once per shift by the establishment by water-tight drain valve shall be used. checking the retort or reel speed using Screens shall be installed over all drain an accurate stopwatch. A means of pre- openings. venting unauthorized speed changes on (vii) Water level. There shall be a retorts shall be provided. For example, means of determining the water level a lock or a notice from management in the retort during operation (i.e., by posted at or near the speed adjustment using a gauge, electronic sensor, or device warning that only authorized sight glass indicator). Water shall com- persons are permitted to make adjust- pletely cover all containers during the ments are satisfactory means of pre- entire come-up, thermal processing, venting unauthorized changes. and cooling periods. A means to ensure (x) Water recirculation. If a water re- that water circulation continues as circulation system is used for heat dis- specified throughout the come-up, tribution, it shall be installed in such a thermal processing, and cooling periods manner that water will be drawn from shall be provided. The retort operator the bottom of the retort through a suc- shall check and record the adequacy of tion manifold and discharged through a the water level with sufficient fre- spreader which extends the length of quency to ensure it meets the specified the top of the retort. The holes in the processing parameters. water spreader shall be uniformly dis- (viii) Air supply and controls. Retorts tributed. The suction outlets shall be shall be provided with a means for in- protected with screens to keep debris troducing compressed air or steam at from entering the recirculation sys- the pressure required to maintain con- tem. The pump shall be equipped with tainer integrity. Compressed air and a pilot light or a similar device to warn steam entry shall be controlled by an the operator when it is not running and automatic pressure control unit. A with a bleeder to remove air when nonreturn valve shall be provided in starting operations. Alternatively, a the air supply line to prevent water flow-meter alarm system can be used from entering the system. Overriding to ensure proper water circulation. The air or steam pressure shall be main- adequacy of water circulation for tained continuously during the come- maintaining uniform heat distribution up, thermal processing, and cooling pe- within the retort shall be documented riods. If air is used to promote circula- by heat distribution data or other doc- tion, it shall be introduced into the umentation from a processing author- steam line at a point between the re- ity and such data shall be maintained

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on file by the establishment and made pheric cooker (e.g., hot water bath) available to Program employees for re- shall be equipped with at least one view. Alternative methods for recir- temperature/time recording device in culation of water in the retort may be accordance with the basic require- used provided there is documentation ments described in paragraph (a)(2) of in the form of heat distribution data or this section. other documentation from a processing (2) Heat distribution. Each atmos- authority maintained on file by the es- pheric cooker shall be equipped and op- tablishment and made available to erated to ensure uniform heat distribu- Program employees for review. tion throughout the processing system (xi) Cooling water entry. In retorts for during the thermal process. Heat dis- processing product packed in glass jars, tribution data or other documentation the incoming cooling water should not from the manufacturer or a processing directly strike the jars, in order to authority demonstrating uniform heat minimize glass breakage by thermal distribution within the cooker shall be shock. kept on file by the establishment and (d) Pressure processing with steam/air made available to Program employees mixtures in batch retorts. (1) The basic for review. requirements for indicating tempera- (f) Other systems. All other systems ture devices and temperature/time re- not specifically delineated in this sec- cording devices are described in para- tion and used for the thermal proc- graphs (a) (1) and (2) of this section. essing of canned product shall be ade- Additionally, bulb sheaths or probes quate to produce shelf-stable products for indicating temperature devices and consistently and uniformly. temperature/time recording devices or (g) Equipment maintenance. (1) Upon controller probes shall be inserted di- installation, all instrumentation and rectly into the retort shell in such a controls shall be checked by the estab- position that steam does not strike lishment for proper functioning and ac- them directly. curacy and, thereafter, at any time (2) Steam controllers are required as their functioning or accuracy is sus- described in paragraph (a)(3) of this pect. section. (2) At least once a year each thermal (3) Recording pressure controller. A reprocessing system shall be examined by cording pressure controller shall be an individual not directly involved in used to control the air inlet and the daily operations to ensure the proper steam/air mixture outlet. functioning of the system as well as all (4) Circulation of steam/air mixture. A auxiliary equipment and instrumenta- means shall be provided for the circulation. In addition, each thermal proc- tion of the steam/air mixture to pre- essing system should be examined be- vent formation of low-temperature fore the resumption of operation fol- pockets. The efficiency of the circula- lowing an extended shutdown. tion system shall be documented by (3) Air and water valves that are in- heat distribution data or other docu- tended to be closed during thermal mentation from a processing authority, processing shall be checked by the es- and such data shall be maintained on tablishment for leaks. Defective valves file by the establishment and made shall be repaired or replaced as needed. available to Program employees for re- (4) Vent and bleeder mufflers shall be view. The circulation system shall be checked and maintained or replaced by checked to ensure its proper func- the establishment to prevent any re- tioning and shall be equipped with a duction in vent or bleeder efficiency. pilot light or a similar device to warn (5) When water spreaders are used for the operator when it is not func- venting, a maintenance schedule shall tioning. Because of the variety of exist- be developed and implemented to as- ing designs, reference shall be made to sure that the holes are maintained at the equipment manufacturer for de- their original size. tails of installation, operation and con- (6) Records shall be kept on all main- trol. tenance items that could affect the (e) Atmospheric cookers—(1) Tempera- adequacy of the thermal process. ture/time recording device. Each atmos- Records shall include the date and type

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of maintenance performed and the per- seal area, containers should not remain son conducting the maintenance. stationary on moving conveyors. All (h) Container cooling and cooling post-process container handling equip- water. (1) Potable water shall be used ment should be kept clean so there is for cooling except as provided for in no buildup of microorganisms on sur- paragraphs (h) (2) and (3) of this sec- faces in contact with the containers. tion. (Approved by the Office of Management and (2) Cooling canal water shall be Budget under control number 0583–0015) chlorinated or treated with a chemical approved by the Administrator as hav- [51 FR 45634, Dec. 19, 1986, as amended at 65 FR 34390, May 30, 2000] ing a bactericidal effect equivalent to chlorination. There shall be a measur- § 381.306 Processing and production able residual of the sanitizer in the records. water at the discharge point of the At least the following processing and canal. Cooling canals shall be cleaned production information shall be re- and replenished with potable water to corded by the establishment: Date of prevent the buildup of organic matter production; product name and style; and other materials. container code; container size and (3) Container cooling waters that are type; and the process schedule, includ- recycled or reused shall be handled in ing the minimum initial temperature. systems that are so designed, operated, Measurements made to satisfy the re- and maintained so there is no buildup quirements of § 381.303 regarding the of microorganisms, organic matter, control of critical factors shall be re- and other materials in the systems and corded. In addition, where applicable, in the waters. System equipment, such the following information and data as pipelines, holding tanks and cooling shall also be recorded: towers, shall be constructed and in- (a) Processing in steam—(1) Batch still stalled so that they can be cleaned and retorts. For each retort batch, record inspected. In addition, the establish- the retort number or other designa- ment shall maintain, and make avail- tion, the approximate number of con- able to Program employees for review, tainers or the number of retort crates information on at least the following: per retort load, product initial tem- (i) System design and construction; perature, time steam on, the time and (ii) System operation including the temperature vent closed, the start of rates of renewal with fresh, potable process timing, time steam off, and the water and the means for treating the actual processing time. The indicating water so that there is a measurable re- temperature device and the tempera- sidual of an acceptable sanitizer, per ture recorder shall be read at the same paragraph (h)(2) of this section, in the time at least once during process tim- water at the point where the water ing and the observed temperatures re- exits the container cooling vessel; corded. (iii) System maintenance including (2) Batch agitating retorts. In addition procedures for the periodic cleaning to recording the information required and sanitizing of the entire system; for batch, still steam retorts in para- and graph (a)(1) of this section, record the (iv) Water quality standards, such as functioning of the condensate bleed- microbiological, chemical and phys- er(s) and the retort or reel speed. ical, monitoring procedures including (3) Continuous rotary retorts. Record the frequency and site(s) of sampling, the retort system number, the approxi- and the corrective actions taken when mate total number of containers re- water quality standards are not met. torted, product initial temperature, (i) Post-process handling of containers. time steam on, the time and tempera- Containers shall be handled in a man- ture vent closed, time process tempera- ner that will prevent damage to the ture reached, the time the first can en- hermetic seal area. All worn and frayed ters and the time the last can exits the belting, can retarders, cushions, and retort. The retort or reel speed shall be the like shall be replaced with non- determined and recorded at intervals porous materials. To minimize con- not to exceed 4 hours. Readings of the tainer abrasions, particularly in the indicating temperature device(s) and

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temperature recorder(s) shall be made process timing and the observed tem- and recorded at the time the first con- peratures recorded. tainer enters the retort and thereafter (2) Batch agitating retorts. In addition with sufficient frequency to ensure to recording the information required compliance with the process schedule. in paragraph (b)(1) of this section, These observations should be made and record the retort or reel speed. recorded at intervals not exceeding 30 (c) Processing in steam/air mixtures. minutes of continuous retort oper- For each retort batch, record the re- ation. Functioning of the condensate tort number or other designation, the bleeder(s) shall be observed and re- approximate number of containers or corded at the time the first container number of retort crates per retort load, enters the retort and thereafter as product initial temperature, time specified in § 381.305(b)(3)(v). steam on, venting procedure, if applicable, the start of process timing, (4) Hydrostatic retorts. Record the re- maintenance of circulation of the tort system number, the approximate steam/air mixture, air flow rate or total number of containers retorted, forced recirculation flow rate (if crit- product initial temperature, time ical), overriding pressure maintained, steam on, the time and temperature time steam off, and actual processing vent(s) closed, time process tempera- time. The indicating temperature de- ture reached, time first containers vice and the temperature recorder shall enter the retort, time last containers be read at the same time at least once exit the retort, and, if specified in the during process timing and the observed process schedule, measurements of temperatures recorded. temperatures in the hydrostatic water (d) Atmospheric cookers—(1) Batch-type legs. Readings of the temperature indi- systems. For each cooker batch, record cating device, which is located in the the cooker number or other designa- steam/water interface, and the tem- tion and the approximate number of perature recording device shall be ob- containers. In addition, record all crit- served and the temperatures recorded ical factors of the process schedule at the time the first containers enter such as cooker temperature, initial the steam dome. Thereafter, these in- temperature, the time the thermal struments shall be read and the tem- process cycle begins and ends, hold peratures recorded with sufficient fre- time, and the final internal product quency to ensure compliance with the temperature. temperature specified in the process (2) Continuous-type systems. Record schedule and should be made at least the cooker number or other designa- every hour of continuous retort oper- tion, the time the first containers ation. Container conveyor speed, and enter and the last containers exit a for agitating hydrostatic retorts, the cooker, and the approximate total rotative chain speed, shall be deter- number of containers processed. In ad- mined and recorded at intervals of suf- dition, record all critical factors of the ficient frequency to ensure compliance process schedule such as the initial with the process schedule and should temperature, cooker speed, and final be performed at least every 4 hours. internal product temperature. (b) Processing in water—(1) Batch still (Approved by the Office of Management and retorts. For each retort batch, record Budget under control number 0583–0015) the retort number or other designation, the approximate number of con- § 381.307 Record review and mainte- tainers or number of retort crates per nance. retort load, product initial tempera- (a) Process records. Charts from tem- ture, time steam on, the start of proc- perature/time recording devices shall ess timing, water level, water recir- be identified by production date, con- culation rate (if critical), overriding tainer code, processing vessel number pressure maintained, time steam off, or other designation and other data as and actual processing time. The indi- necessary to enable correlation with cating temperature device and the the records required in § 381.306. Each temperature recorder shall be read at entry on a record shall be made at the the same time at least once during time the specific event occurs, and the

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recording individual shall sign or ini- available to Program employees within tial each record form. No later than 1 3 working days. working day after the actual process, (Approved by the Office of Management and the establishment shall review all Budget under control number 0583–0015) processing and production records to ensure completeness and to determine [51 FR 45634, Dec. 19, 1986, as amended at 65 FR 34390, May 30, 2000] if all product received the process schedule. All records, including the § 381.308 Deviations in processing. temperature/time recorder charts and critical factor control records, shall be (a) Whenever the actual process is signed or initialed and dated by the less than the process schedule or when any critical factor does not comply person conducting the review. All proc- with the requirements for that factor essing and production records required as specified in the process schedule, it in this subpart shall be made available shall be considered a deviation in proc- to Program employees for review. essing. (b) Automated process monitoring and (b) Deviations in processing (or proc- recordkeeping. Automated process mon- ess deviations) must be handled accord- itoring and recordkeeping systems ing to: shall be designed and operated in a (1)(i) A HACCP plan for canned prod- manner which will ensure compliance uct that addresses hazards associated with the applicable requirements of with microbial contamination, or, § 381.306. (ii) Alternative documented proce- (c) Container closure records. Written dures that will ensure that only safe records of all container closure exami- and stable product is shipped in com- nations shall specify the container merce; or code, the date and time of container (iii) Paragraph (d) of this section. closure examination, the measure- (2) Paragraph (d) of this section. ment(s) obtained, and any corrective (c) [Reserved] actions taken. Records shall be signed (d) Procedures for handling process or initialed by the container closure deviations where the HACCP plan for technician and shall be reviewed and thermally processed/commercially signed by the establishment within 1 sterile product does not address food working day after the actual produc- safety hazards associated with micro- tion to ensure that the records are bial contamination, where there is no complete and that the closing oper- approved total quality control system, ations have been properly controlled. or where the establishment has no al- All container closure examination ternative documented procedures for records required in this subpart shall handling process deviations. be made available to Program employ- (1) Deviations identified in-process. If a ees for review. deviation is noted at any time before (d) Distribution of product. Records the completion of the intended process shall be maintained by the establish- schedule, the establishment shall: ment identifying initial distribution of (i) Immediately reprocess the prod- the finished product to facilitate, if uct using the full process schedule; or, necessary, the segregation of specific (ii) Use an appropriate alternate production lots that may have been process schedule provided such a proc- contaminated or are otherwise unsound ess schedule has been established in ac- for their intended use. cordance with § 381.302 (a) and (b) and is (e) Retention of records. Copies of all filed with the inspector in accordance processing and production records re- with § 381.302(c); or, quired in § 381.306 shall be retained for (iii) Hold the product involved and no less than 1 year at the establish- have the deviation evaluated by a processing authority to assess the safety ment, and for an additional 2 years at and stability of the product. Upon com- the establishment or other location pletion of the evaluation, the establish- from which the records can be made ment shall provide the inspector the following:

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(a) A complete description of the de- ule, the reel shall be stopped and the viation along with all necessary sup- following actions shall be taken: porting documentation; (1) For temperature drops of less (b) A copy of the evaluation report; than 10 °F (or 5.5 °C) either (i) all con- and, tainers in the retort shall be given an (c) A description of any product dis- emergency still process (developed per position actions, either taken or pro- § 381.302(b)) before the reel is restarted; posed. (ii) container entry to the retort shall (iv) Product handled in accordance be prevented and an emergency agi- with paragraph (d)(1)(iii) of this section tating process (developed per shall not be shipped from the establish- § 381.302(b)) shall be used before con- ment until the Program has reviewed tainer entry to the retort is restarted; all of the information submitted and or (iii) container entry to the retort approved the product disposition ac- shall be prevented and the reel re- tions. started to empty the retort. The dis- (v) If an alternate process schedule is charged containers shall be reproc- used that is not on file with the inspec- essed, repacked and reprocessed, or de- tor or if an alternate process schedule stroyed. Product to be destroyed shall is immediately calculated and used, be handled as ‘‘U.S. Inspected and Con- the product shall be set aside for fur- demned’’, as defined in § 301.2(ee) of this ther evaluation in accordance with chapter, and disposed of in accordance paragraphs (d)(1) (iii) and (iv) of this with part 314 of this chapter. section. (2) For temperature drops of 10 °F (or (vi) When a deviation occurs in a con- 5.5 °C) or more, all containers in the re- tinuous rotary retort, the product shall tort shall be given an emergency still be handled in accordance with para- process (developed per § 381.302(b)). The graphs (d)(1) (iii) and (iv) of this sec- time the reel was stopped and the time tion or in accordance with the fol- the retort was used for a still retort lowing procedures: process shall be marked on the tem- (a) Emergency stops. perature/time recording device by the (1) When retort jams or breakdowns establishment and entered on the other occur during the processing operations, production records required in § 381.306. all containers shall be given an emer- Alternatively, container entry to the gency still process (developed per retort shall be prevented and the reel § 381.302(b)) before the retort is cooled restarted to empty the retort. The dis- or the retort shall be cooled promptly charged containers shall be either re- and all containers removed and either processed, repacked and reprocessed, or reprocessed, repacked and reprocessed, destroyed. Product to be destroyed or destroyed. Regardless of the proce- shall be handled as ‘‘U.S. Inspected and dure used, containers in the retort in- Condemned’’ as defined in § 301.2(ee) of take valve and in transfer valves be- this chapter, and disposed of in accord- tween retort shells at the time of a jam ance with part 314 of this chapter. or breakdown shall be removed and ei- (2) Deviations identified through record ther reprocessed, repacked and reproc- review. Whenever a deviation is noted essed, or destroyed. Product to be de- during review of the processing and stroyed shall be handled as ‘‘U.S. In- production records required by § 381.307 spected and Condemned’’, as defined in (a) and (b), the establishment shall § 301.2(ee) of this chapter, and disposed hold the product involved and the devi- of in accordance with part 314 of this ation shall be handled in accordance chapter. with paragraphs (d)(1) (iii) and (iv) of (2) The time the retort reel stopped this section. and the time the retort is used for an (e) Process deviation file. The estab- emergency still retort process shall be lishment shall maintain full records re- noted on the temperature/time record- garding the handling of each deviation. ing device and entered on the other Such records shall include, at a min- production records required in § 381.306. imum, the appropriate processing and (b) Temperature drops. When the re- production records, a full description of tort temperature drops below the tem- the corrective actions taken, the eval- perature specified in the process sched- uation procedures and results, and the

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disposition of the affected product. time the sample containers were held Such records shall be maintained in a at the deviant temperature. If the incu- separate file or in a log that contains bation temperature is at or above 103 the appropriate information. The file °F (or 39.5 °C) for more than 2 hours, or log shall be retained in accordance the incubation test(s) shall be termi- with § 381.307(e) and shall be made nated, the temperature lowered to available to Program employees upon within the required range, and new request. sample containers incubated for the re- (Approved by the Office of Management and quired time. Budget under control number 0583–0015) (iii) Product requiring incubation. Shelf stable product requiring incuba- [51 FR 45634, Dec. 19, 1986, as amended at 62 tion includes: FR 45027, Aug. 25, 1997; 65 FR 34390, May 30, 2000; 65 FR 53533, Sept. 5, 2000] (a) Low acid products as defined in § 381.300(m); and § 381.309 Finished product inspection. (b) Acidified low acid products as de- (a) Finished product inspections fined in § 381.300(b). must be handled according to: (iv) Incubation samples. (a) From each (1) A HACCP plan for canned product load of product processed in a batch- that addresses hazards associated with type thermal processing system (still microbiological contamination; or or agitation), the establishment shall (2) An FSIS-approved total quality select at least one container for incu- control system; or bation. (3) Alternative documented proce- (b) For continuous rotary retorts, hy- dures that will ensure that only prod- drostatic retorts, or other continuous- uct that is safe and stable is shipped in type thermal processing systems, the commerce; or establishment shall select at least one (4) Paragraph (d) of this section. container per 1,000 for incubation. (b)–(c) [Reserved] (c) Only normal-appearing containers (d) Procedures for finished product shall be selected for incubation. inspections where the HACCP plan for (v) Incubation time. Canned product thermally processed/commercially requiring incubation shall be incubated sterile product does not address food for not less than 10 days (240 hours) safety hazards associated with micro- under the conditions specified in para- bial contamination, where there is no graph (d)(1)(ii) of this section. approved total quality control system, (vi) Incubation checks and record main- or where the establishment has no al- tenance. Designated establishment em- ternative documented procedures for ployees shall visually check all con- handling process deviations. tainers under incubation each working (1) Incubation of shelf stable canned day and the inspector shall be notified product—(i) Incubator. The establish- when abnormal containers are de- ment shall provide incubation facilities tected. All abnormal containers should which include an accurate tempera- be allowed to cool before a final deci- ture/time recording device, an indi- sion on their condition is made. For cating temperature device, a means for each incubation test the establishment the circulation of the air inside the in- shall record at least the product name, cubator to prevent temperature vari- container size, container code, number ations, and a means to prevent unau- of containers incubated, in and out thorized entry into the facility. The dates, and incubation results. The es- Program is responsible for the security tablishment shall retain such records, of the incubator. along with copies of the temperature/ (ii) Incubation temperature. The incu- time recording charts, in accordance bation temperature shall be main- with § 381.307(e). tained at 95±5 °F (35±2.8 °C). If the incu- (vii) Abnormal containers. The finding bation temperature falls below 90 °F (or of abnormal containers (as defined in 32 °C) or exceeds 100 °F (or 38 °C) but § 381.300(a)) among incubation samples does not reach 103 °F (or 39.5 °C), the is cause to officially retain at least the incubation temperature shall be ad- code lot involved. justed within the required range and (viii) Shipping. No product shall be the incubation time extended for the shipped from the establishment before

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the end of the required incubation pe- § 381.311 Recall procedure. riod except as provided in this para- Establishments shall prepare and graph or paragraph (b) or (c) of this section. An establishment wishing to maintain a current procedure for the ship product prior to the completion of recall of all canned product covered by the required incubation period shall this subpart. Upon request, the recall submit a written proposal to the area procedure shall be made available to supervisor. Such a proposal shall in- Program employees for review. clude provisions that will assure that (Approved by the Office of Management and shipped product will not reach the re- Budget under control number 0583–0015) tail level of distribution before sample incubation is completed and that product can be returned promptly to the es- Subpart Y—Nutrition Labeling tablishment should such action be deemed necessary by the incubation SOURCE: 58 FR 675, Jan. 6, 1993, unless oth- test results. Upon receipt of written erwise noted. approval from the area supervisor, product may be routinely shipped pro- § 381.400 Nutrition labeling of poultry vided the establishment continues to products. comply with all requirements of this (a) Nutrition labeling must be pro- subpart. vided for all poultry products intended (2) Container condition. (i) Normal con- for human consumption and offered for tainers. Only normal-appearing con- sale, except single-ingredient, raw tainers shall be shipped from an estab- poultry products that are not ground lishment as determined by an appro- or chopped poultry products described priate sampling plan or other means in § 381.401 and are not major cuts of acceptable to Program employees. single-ingredient, raw poultry products (ii) Abnormal containers. When abnor- identified in § 381.444, unless the prod- mal containers are detected by any uct is exempted under § 381.500. Nutri- means other than incubation, the es- tion labeling must be provided for the tablishment shall inform the inspector major cuts of single-ingredient, raw and the affected code lot(s) shall not be poultry products identified in § 381.444, shipped until the Program has deter- either in accordance with the provi- mined that the product is safe and stable. Such a determination will take sions of § 381.409 for nutrition labels, or into account the cause and level of in accordance with the provisions of abnormals in the affected lot(s) as well § 381.445 for point-of-purchase mate- as any product disposition actions ei- rials, except as exempted under ther taken or proposed by the estab- § 381.500. For all other products that re- lishment. quire nutrition labeling, including ground or chopped poultry products de- (Approved by the Office of Management and scribed in § 381.401, nutrition labeling Budget under control number 0583–0015) must be provided in accordance with [51 FR 45634, Dec. 19, 1986, as amended at 57 the provisions of § 381.409, except as ex- FR 37872, Aug. 21, 1992; 57 FR 55443, Nov. 25, empted under § 381.500. 1992; 62 FR 45027, Aug. 25, 1997; 65 FR 34391, May 30, 2000; 65 FR 53533, Sept. 5, 2000] (b) Nutrition labeling may be provided for single-ingredient, raw poultry § 381.310 Personnel and training. products that are not ground or All operators of thermal processing chopped poultry products described in systems specified in § 381.305 and con- § 381.401 and that are not major cuts of tainer closure technicians shall be single-ingredient, raw poultry products under the direct supervision of a person identified in § 381.444, either in accord- who has successfully completed a ance with the provisions of § 381.409 for school of instruction that is generally nutrition labels, or in accordance with recognized as adequate for properly the provisions of § 381.445 for point-of- training supervisors of canning oper- purchase materials. ations. [75 FR 82166, Dec. 29, 2010] [51 FR 45634, Dec. 19, 1986]

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§ 381.401 Required nutrition labeling such package shall meet the require- of ground or chopped poultry prod- ments of § 381.121(c)(7). ucts. § 381.409 Nutrition label content. Nutrition labels must be provided for all ground or chopped poultry (kind) (a) All nutrient and food component with or without added seasonings (in- quantities shall be declared in relation cluding, but not limited to, ground to a serving as defined in this section. chicken, ground turkey, and (kind) (b)(1) The term ‘‘serving’’ or ‘‘serving burgers) that are intended for human size’’ means an amount of food custom- consumption and offered for sale, in ac- arily consumed per eating occasion by cordance with the provisions of persons 4 years of age or older, which is § 381.409, except as exempted under expressed in a common household § 381.500. measure that is appropriate to the product. When the product is specially [75 FR 82166, Dec. 29, 2010] formulated or processed for use by infants or by toddlers, a serving or serv- § 381.402 Location of nutrition infor- ing size means an amount of food cus- mation. tomarily consumed per eating occasion (a) Nutrition information on a label by infants up to 12 months of age or by of a packaged poultry product shall ap- children 1 through 3 years of age, re- pear on the label’s principal display spectively. panel or on the information panel, ex- (2) Except as provided in paragraphs cept as provided in paragraphs (b) and (b)(8), (b)(12), and (b)(14) of this section (c) of this section. and for products that are intended for (b) Nutrition information for gift weight control and are available only packs may be shown at a location through a weight-control or weight- other than on the product label, pro- maintenance program, the serving size vided that the labels for these products declared on a product label shall be de- bear no nutrition claim. In lieu of on termined from the ‘‘Reference the product label, nutrition informa- Amounts Customarily Consumed Per tion may be provided by alternate Eating Occasion—General Food Sup- means such as product label inserts. ply’’ (Reference Amount(s)) that appear in § 381.412(b) using the procedures (c) Poultry products in packages that described in this paragraph (b). For have a total surface area available to products that are both intended for bear labeling greater than 40 square weight control and available only inches but whose principal display through a weight-control program, a panel and information panel do not manufacturer may determine the serv- provide sufficient space to accommo- ing size that is consistent with the date all required information may use meal plan of the program. Such prod- any alternate panel that can be readily ucts must bear a statement, ‘‘for sale seen by consumers for the nutrition in- only through the lll program’’ (fill formation. In determining the suffi- in the blank with the name of the ap- ciency of available space for the nutri- propriate weight-control program, e.g., tion information, the space needed for Smith’s Weight Control), on the prin- vignettes, designs, and other non- cipal display panel. However, the Ref- mandatory label information on the erence Amounts in § 381.412(b) shall be principal display panel may be consid- used for purposes of evaluating wheth- ered. er weight-control products that are [58 FR 675, Jan. 6, 1993, as amended at 59 FR available only through a weight-con- 40215, Aug. 8, 1994] trol program qualify for nutrition claims. §§ 381.403–381.407 [Reserved] (3) The declaration of nutrient and food component content shall be on the § 381.408 Labeling of poultry products basis of the product ‘‘as packaged’’ for with number of servings. all products, except that single-ingre- The label of any package of a poultry dient, raw products that are not ground product that bears a representation as or chopped poultry products as de- to the number of servings contained in scribed in § 381.401 may be declared on

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the basis of the product ‘‘as con- (vi) For products which consist of sumed.’’ For single-ingredient, raw two or more foods packaged and pre- products that are not ground or sented to be consumed together where chopped poultry products described in the ingredient represented as the main § 381.401, if data are based on the prod- ingredient is in discrete units (e.g., uct ‘‘as consumed,’’ the data must be chicken wings and barbecue sauce), the presented in accordance with serving size may be the number of dis- § 381.445(d). In addition to the required crete units represented as the main in- declaration on the basis of ‘‘as pack- gredient plus proportioned minor in- aged’’ for products other than single- gredients used to make the Reference ingredient, raw products that are not Amount for the combined product as ground or chopped poultry products as determined in § 381.412(c). described in § 381.401, the declaration (vii) For packages containing several may also be made on the basis of ‘‘as individual single-serving containers, consumed,’’ provided that preparation each of which is labeled with all re- and cooking instructions are clearly quired information including nutrition stated. labeling as specified in this section (4) For products in discrete units (i.e., are labeled appropriately for indi- (e.g., chicken wings, and individually vidual sale as single-serving con- packaged products within a multi-serv- tainers), the serving size shall be 1 ing package), and for products which unit. consist of two or more foods packaged (5) For products in large discrete and presented to be consumed together units that are usually divided for con- where the ingredient represented as the sumption (e.g., pizza, pan of poultry main ingredient is in discrete units lasagna), for unprepared products (e.g., chicken wings and barbecue where the entire contents of the pack- sauce), the serving size shall be de- age is used to prepare large discrete clared as follows: units that are usually divided for consumption (e.g., pizza kit), and for prod- (i) If a unit weighs 50 percent or less ucts which consist of two or more foods of the Reference Amount, the serving packaged and presented to be con- size shall be the number of whole units sumed together where the ingredient that most closely approximates the represented as the main ingredient is a Reference Amount for the product cat- large discrete unit usually divided for egory. consumption, the serving size shall be (ii) If a unit weighs more than 50 per- the fractional slice of the ready-to-eat cent but less than 67 percent of the product (e.g., 1⁄8 quiche, 1⁄4 pizza) that Reference Amount, the manufacturer most closely approximates the Ref- may declare one unit or two units as erence Amount for the product cat- the serving size. egory. The serving size may be the (iii) If a unit weighs 67 percent or fraction of the package used to make more but less than 200 percent of the the Reference Amount for the unpre- Reference Amount, the serving size pared product determined in § 381.412(d) shall be one unit. or the fraction of the large discrete (iv) If a unit weighs 200 percent or unit represented as the main ingre- more of the Reference Amount, the dient plus proportioned minor ingredi- manufacturer may declare one unit as ents used to make the Reference the serving size if the whole unit can Amount of the combined product deter- reasonably be consumed at a single mined in § 381.412(c). In expressing the eating occasion. fractional slice, manufacturers shall (v) For products that have Reference use 1⁄2, 1⁄3, 1⁄4, 1⁄5, 1⁄6, or smaller fractions Amounts of 100 grams (or milliliter) or that can be generated by further divi- larger and are individual units within a sion by 2 or 3. multi-serving package, if a unit con- (6) For nondiscrete bulk products tains more than 150 percent but less (e.g., whole turkey, turkey breast, than 200 percent of the Reference ground poultry), and for products Amount, the manufacturer may decide which consist of two or more foods whether to declare the individual unit packaged and presented to be con- as 1 or 2 servings. sumed together where the ingredient

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represented as the main ingredient is a used for other products in discrete bulk product (e.g., turkey breast and units (e.g., wing, slice, link, or patty). gravy), the serving size shall be the (v) For unprepared products where amount in household measure that the entire contents of the package is most closely approximates the Ref- used to prepare large discrete units erence Amount for the product cat- that are usually divided for consump- egory and may be the amount of the tion (e.g., pizza kit), the fraction or bulk product represented as the main portion of the package may be used. ingredient plus proportioned minor in- (vi) For products that consist of two gredients used to make the Reference or more distinct ingredients or compo- Amount for the combined product de- nents packaged and presented to be termined in § 381.412(c). consumed together (e.g., chicken wings (7) For labeling purposes, the term with a glaze packet), the nutrition in- ‘‘common household measure’’ or formation may be declared for each ‘‘common household unit’’ means cup, component or as a composite. The serv- tablespoon, teaspoon, piece, slice, frac- ing size may be provided in accordance tion (e.g., 1⁄4 pizza), ounce (oz), or other with the provisions of paragraphs common household equipment used to (b)(4), (b)(5), and (b)(6) of this section. package food products (e.g., jar or (vii) For nutrition labeling purposes, tray). In expressing serving size in a teaspoon means 5 milliliters (mL), a household measures, except as speci- tablespoon means 15 mL, a cup means fied in paragraphs (b)(7)(iv), (v), and 240 mL, and 1 oz in weight means 28 (vi) of this section, the following rules grams (g). shall be used: (viii) When a serving size, determined (i) Cups, tablespoons, or teaspoons from the Reference Amount in shall be used wherever possible and ap- § 381.412(b) and the procedures described in this section, falls exactly half way propriate. Cups shall be expressed in 1⁄4- between two serving sizes (e.g., 2.5 or 1⁄3-cup increments, tablespoons in tbsp), manufacturers shall round the whole number of tablespoons for quan- serving size up to the next incremental tities less than 1⁄4 cup but greater than size. or equal to 2 tablespoons (tbsp), 1, 11⁄3, (8) A product that is packaged and 11⁄2, or 12⁄3 tbsp for quantities less than sold individually and that contains less 2 tbsp but greater than or equal to 1 than 200 percent of the applicable Ref- tbsp, and teaspoons in whole number of erence Amount shall be considered to teaspoons for quantities less than 1 be a single-serving container, and the tbsp but greater than or equal to 1 tea- entire content of the product shall be spoon (tsp), and in 1⁄4-tsp increments labeled as one serving, except for prod- for quantities less than 1 tsp. ucts that have Reference Amounts of (ii) If cups, tablespoons or teaspoons 100 g (or mL) or larger, manufacturers are not applicable, units such as piece, may decide whether a package that slice, tray, jar, and fraction shall be contains more than 150 percent but less used. than 200 percent of the Reference (iii) If cups, tablespoons and Amount is 1 or 2 servings. Packages teaspoons, or units such as piece, slice, sold individually that contain 200 per- tray, jar, or fraction are not applicable, cent or more of the applicable Ref- ounces may be used. Ounce measure- erence Amount may be labeled as a sin- ments shall be expressed in 0.5-ounce gle-serving if the entire content of the increments most closely approxi- package can reasonably be consumed mating the Reference Amount with at a single-eating occasion. rounding indicated by the use of the (9) A label statement regarding a term ‘‘about’’ (e.g., about 2.5 ounces). serving shall be the serving size ex- (iv) A description of the individual pressed in common household measures container or package shall be used for as set forth in paragraphs (b)(2) single-serving containers and for indi- through (b)(8) of this section and shall vidually packaged products within be followed by the equivalent metric multi-serving containers (e.g., can, quantity in parenthesis (fluids in milli- box, package, meal, or dinner). A de- liters and all other foods in grams), ex- scription of the individual unit shall be cept for single-serving containers.

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(i) For a single-serving container, the basis and the number of servings varies parenthetical metric quantity, which because of a natural variation in unit will be presented as part of the net size, the manufacturer may state the weight statement on the principal dis- typical number of servings per con- play panel, is not required except tainer (e.g., usually 5 servings). where nutrition information is re- (iii) For random weight products, a quired on a drained weight basis ac- manufacturer may declare ‘‘varied’’ for cording to paragraph (b)(11) of this sec- the number of servings per container tion. However, if a manufacturer vol- provided the nutrition information is untarily provides the metric quantity based on the Reference Amount ex- on products that can be sold as single pressed in ounces. The manufacturer servings, then the numerical value pro- may provide the typical number of vided as part of the serving size dec- servings in parenthesis following the laration must be identical to the met- ‘‘varied’’ statement (e.g., varied (ap- ric quantity declaration provided as proximately 8 servings per pound)). part of the net quantity of contents (iv) For packages containing several statement. individual single-serving containers, (ii) The gram or milliliter quantity each of which is labeled with all re- equivalent to the household measure quired information including nutrition should be rounded to the nearest whole labeling as specified in this section number except for quantities that are (i.e., are labeled appropriately for indi- less than 5 g (mL). The gram (mL) vidual sale as single-serving con- quantity between 2 and 5 g (mL) should tainers), the number of servings shall be rounded to the nearest 0.5 g (mL) be the number of individual packages and the g (mL) quantity less than 2 g within the total package. (mL) should be expressed in 0.1-g (mL) (v) For packages containing several increments. individually packaged multi-serving (iii) In addition, serving size may be units, the number of servings shall be declared in ounce, in parenthesis, fol- determined by multiplying the number lowing the metric measure separated of individual multi-serving units in the by a slash where other common house- total package by the number of hold measures are used as the primary servings in each individual unit. The unit for serving size, e.g., 1 slice (28 g/ declaration of the number of servings 1 oz) for sliced chicken roll. The ounce per container need not be included in quantity equivalent to the metric nutrition labeling of single-ingredient, quantity should be expressed in 0.1-oz raw poultry products that are not increments. ground or chopped poultry products de- (iv) If a manufacturer elects to use scribed in § 381.401, including those that abbreviations for units, the following have been previously frozen. abbreviations shall be used: tbsp for ta- (11) The declaration of nutrient and blespoon, tsp for teaspoon, g for gram, food component content shall be on the mL for milliliter, and oz for ounce. basis of product as packaged or pur- (10) Determination of the number of chased with the exception of single-in- servings per container shall be based gredient, raw products that are not on the serving size of the product de- ground or chopped poultry products determined by following the procedures scribed in § 381.401 and products that described in this section. are packed or canned in water, brine, (i) The number of servings shall be or oil but whose liquid packing me- rounded to the nearest whole number dium is not customarily consumed. except for the number of servings be- Declaration of the nutrient and food tween 2 and 5 servings and random component content of products that weight products. The number of are packed in liquid which is not cus- servings between 2 and 5 servings shall tomarily consumed shall be based on be rounded to the nearest 0.5 serving. the drained solids. Rounding should be indicated by the (12) The serving size for meal-type use of the term ‘‘about’’ (e.g., about 2 products and main-dish products as de- servings; about 3.5 servings). fined in § 381.413(l) and § 381.413 (m) in (ii) When the serving size is required single-serve containers will be the en- to be expressed on a drained solids tire edible content of the package.

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Serving size for meal-type products and voluntary may be included within the main-dish products in multi-serve con- nutrition label. Except as provided for tainers will be based on the reference in paragraph (f) or (g) of this section, amount applicable to the product in nutrient information shall be presented § 381.412(b) if the product is listed in using the nutrient names specified and § 381.412(b). Serving size for meal-type in the following order in the formats products and main-dish products in specified in paragraph (d) or (e) of this multi-serve containers that are not section. listed in § 381.412(b) will be based on the (1) ‘‘Calories, total,’’ ‘‘Total cal- reference amount according to ories,’’ or ‘‘Calories’’: A statement of § 381.412(c), (d), and (e). the caloric content per serving, ex- (13) Another column of figures may pressed to the nearest 5-calorie incre- be used to declare the nutrient and ment up to and including 50 calories, food component information in the and 10-calorie increment above 50 cal- same format as required by § 381.409(e), ories, except that amounts less than 5 (i) Per 100 grams, 100 milliliters, or 1 calories may be expressed as zero. En- ounce of the product as packaged or ergy content per serving may also be purchased. expressed in kilojoule units, added in (ii) Per one unit if the serving size of parenthesis immediately following the a product in discrete units in a multi- statement of the caloric content. serving container is more than one (i) Caloric content may be calculated unit. by the following methods. Where either (14) If a product consists of assort- specific or general food factors are ments of poultry products (e.g., variety used, the factors shall be applied to the packs) in the same package, nutrient actual amount (i.e., before rounding) of content shall be expressed on the en- food components (e.g., fat, carbo- tire package contents or on each indi- hydrate, protein, or ingredients with vidual product. specific food factors) present per serv- (15) If a product is commonly com- ing. bined with other ingredients or is (A) Using specific Atwater factors cooked or otherwise prepared before (i.e., the Atwater method) given in eating, and directions for such com- Table 13, page 25, ‘‘Energy Value of bination or preparations are provided, Foods—Basis and Derivation,’’ by A. L. another column of figures may be used Merrill and B. K. Watt, United States to declare the nutrient contents on the Department of Agriculture (USDA), basis of the product as consumed for Agriculture Handbook No. 74 (Slightly the product alone (e.g., a cream soup revised February 1973), which is incor- mix may be labeled with one set of porated by reference. Table 13 of the Daily Values for the dry mix (per serv- ‘‘Energy Value of Foods—Basis and ing), and another set for the serving of Derivation,’’ Agriculture Handbook No. the final soup when prepared (e.g., per 74 is incorporated as it exists on the serving of cream soup mix and 1 cup of date of approval. This incorporation by vitamin D fortified whole milk)): Pro- reference was approved by the Director vided, that the type and quantity of the of the Federal Register in accordance other ingredients to be added to the with 5 U.S.C. 552(a) and 1 CFR part 51. product by the user and the specific It is available for inspection at the of- method of cooking and other prepara- fice of the FSIS Docket Clerk, Room tion shall be specified prominently on 3171, South Building, 14th and Inde- the label. pendence Avenue, SW., Washington, (c) The declaration of nutrition infor- DC, or at the National Archives and mation on the label or in labeling of a Records Administration (NARA). For poultry product shall contain informa- information on the availability of this tion about the level of the following material at NARA, call 202–741–6030, or nutrients, except for those nutrients go to: http://www.archives.gov/ whose inclusion, and the declaration of federallregister/ amounts, is voluntary as set forth in codeloflfederallregulations/ this paragraph. No nutrients or food ibrllocations.html. Copies of the incor- components other than those listed in poration by reference are available this paragraph as either mandatory or from the Product Assessment Division,

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Regulatory Programs, Food Safety and section per serving may be declared Inspection Service, U.S. Department of voluntarily, expressed to the nearest 5- Agriculture, Room 329, West End Court calorie increment, up to and including Building, Washington, DC 20250–3700; 50 calories, and the nearest 10-calorie (B) Using the general factors of 4, 4, increment above 50 calories, except and 9 calories per gram for protein, that amounts less than 5 calories may total carbohydrate, and total fat, re- be expressed as zero. This statement spectively, as described in USDA’s Ag- shall be indented under the statement riculture Handbook No. 74 (Slightly re- of calories from fat as provided in para- vised February 1973), pages 9–11, which graph (d)(5) of this section. is incorporated by reference. Pages 9– (2) ‘‘Fat, total’’ or ‘‘Total fat’’: A 11, Agriculture Handbook No. 74 is in- statement of the number of grams of corporated as it exists on the date of total fat per serving defined as total approval. This incorporation by ref- lipid fatty acids and expressed as erence was approved by the Director of triglycerides. Amounts shall be ex- the Federal Register in accordance pressed to the nearest 0.5 (1⁄2)-gram in- with 5 U.S.C. 552(a) and 1 CFR part 51. crement below 5 grams and to the near- (The availability of this incorporation est gram increment above 5 grams. If by reference is given in paragraph the serving contains less than 0.5 gram, (c)(1)(i)(A) of this section.); the content shall be expressed as zero. (C) Using the general factors of 4, 4, (i) ‘‘Saturated fat’’ or ‘‘Saturated’’: A and 9 calories per gram for protein, statement of the number of grams of total carbohydrate less the amount of saturated fat per serving defined as the insoluble dietary fiber, and total fat, sum of all fatty acids containing no respectively, as described in USDA’s double bonds, except that label dec- Agriculture Handbook No. 74 (Slightly laration of saturated fat content infor- revised February 1973), pages 9–11, mation is not required for products which is incorporated by reference in that contain less than 0.5 gram of total accordance with 5 U.S.C. 552(a) and 1 fat per serving if no claims are made CFR part 51. (The availability of this about fat or cholesterol content, and if incorporation by reference is given in ‘‘calories from saturated fat’’ is not de- paragraph (c)(1)(i)(A) of this section.); clared. Saturated fat content shall be or indented and expressed as grams per (D) Using data for specific food fac- serving to the nearest 0.5 (1⁄2)-gram in- tors for particular foods or ingredients crement below 5 grams and to the near- approved by the Food and Drug Admin- est gram increment above 5 grams. If istration (FDA) and provided in parts the serving contains less than 0.5 gram, 172 or 184 of 21 CFR, or by other means, the content shall be expressed as zero. as appropriate. (A) ‘‘Stearic Acid’’ (VOLUNTARY): A (ii) ‘‘Calories from fat’’: A statement statement of the number of grams of of the caloric content derived from stearic acid per serving may be de- total fat as defined in paragraph (c)(2) clared voluntarily, except that when a of this section per serving, expressed to claim is made about stearic acid, label the nearest 5-calorie increment, up to declaration shall be required. Stearic and including 50 calories, and the near- acid content shall be indented under est 10-calorie increment above 50 cal- saturated fat and expressed to the ories, except that label declaration of nearest 0.5 (1⁄2)-gram increment below 5 ‘‘calories from fat’’ is not required on grams and the nearest gram increment products that contain less than 0.5 above 5 grams. If the serving contains gram of fat per serving and amounts less than 0.5 gram, the content shall be less than 5 calories may be expressed as expressed as zero. zero. This statement shall be declared (B) [Reserved] as provided in paragraph (d)(5) of this (ii) ‘‘Polyunsaturated fat’’ or ‘‘Poly- section. unsaturated’’ (VOLUNTARY): A state- (iii) ‘‘Calories from saturated fat’’ or ment of the number of grams of poly- ‘‘Calories from saturated’’ (VOL- unsaturated fat per serving defined as UNTARY): A statement of the caloric cis,cis-methylene-interrupted poly- content derived from saturated fat as unsaturated fatty acids may be de- defined in paragraph (c)(2)(i) of this clared voluntarily, except that when

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monounsaturated fat is declared, or the serving contains greater than 140 when a claim about fatty acids or cho- milligrams. lesterol is made on the label or in la- (5) ‘‘Potassium’’ (VOLUNTARY): A beling of a product other than one that statement of the number of milligrams meets the criteria in § 381.462(b)(1) for a of potassium per serving may be de- claim for ‘‘fat free,’’ label declaration clared voluntarily, except that when a of polyunsaturated fat is required. claim is made about potassium con- Polyunsaturated fat content shall be tent, label declaration shall be re- indented and expressed as grams per quired. Potassium content shall be ex- serving to the nearest 0.5 (1⁄2)-gram in- pressed as zero when the serving con- crement below 5 grams and to the near- tains less than 5 milligrams of potas- est gram increment above 5 grams. If sium, to the nearest 5-milligram incre- the serving contains less than 0.5 gram, ment when the serving contains 5 to the content shall be expressed as zero. 140 milligrams of potassium, and to the (iii) ‘‘Monounsaturated fat’’ or nearest 10-milligram increment when ‘‘Monounsaturated’’ (VOLUNTARY): A the serving contains greater than 140 statement of the number of grams of milligrams. monounsaturated fat per serving de- (6) ‘‘Carbohydrate, total’’ or ‘‘Total fined as cis-monounsaturated fatty carbohydrate’’: A statement of the acids may be declared voluntarily, ex- number of grams of total carbohydrate cept that when polyunsaturated fat is per serving expressed to the nearest declared, or when a claim about fatty gram, except that if a serving contains less than 1 gram, the statement ‘‘Con- acids or cholesterol is made on the tains less than 1 gram’’ or ‘‘less than 1 label or in labeling of a product other gram’’ may be used as an alternative, than one that meets the criteria in or, if the serving contains less than 0.5 § 381.462(b)(1) for a claim for ‘‘fat free,’’ gram, the content may be expressed as label declaration of monounsaturated zero. Total carbohydrate content shall fat is required. Monounsaturated fat be calculated by subtraction of the sum content shall be indented and expressed of the crude protein, total fat, mois- as grams per serving to the nearest 0.5 ture, and ash from the total weight of (1⁄2)-gram increment below 5 grams and the product. This calculation method is to the nearest gram increment above 5 described in USDA’s Agriculture Hand- grams. If the serving contains less than book No. 74 (Slightly revised February 0.5 gram, the content shall be expressed 1973), pages 2 and 3, which is incor- as zero. porated by reference. Pages 2 and 3, Ag- (3) ‘‘Cholesterol’’: A statement of the riculture Handbook No. 74 is incor- cholesterol content per serving ex- porated as it exists on the date of ap- pressed in milligrams to the nearest 5- proval. This incorporation by reference milligram increment, except that label was approved by the Director of the declaration of cholesterol information Federal Register in accordance with 5 is not required for products that con- U.S.C. 552(a) and 1 CFR part 51. (The tain less than 2 milligrams of choles- availability of this incorporation by terol per serving and make no claim reference is given in paragraph about fat, fatty acids, or cholesterol (c)(1)(i)(A) of this section.). content, or such products may state (i) ‘‘Dietary fiber’’: A statement of the cholesterol content as zero. If the the number of grams of total dietary product contains 2 to 5 milligrams of fiber per serving, indented and ex- cholesterol per serving, the content pressed to the nearest gram, except may be stated as ‘‘less than 5 milli- that if a serving contains less than 1 grams.’’ gram, declaration of dietary fiber is (4) ‘‘Sodium’’: A statement of the not required, or, alternatively, the number of milligrams of sodium per statement ‘‘Contains less than 1 gram’’ serving expressed as zero when the or ‘‘less than 1 gram’’ may be used, and serving contains less than 5 milligrams if the serving contains less than 0.5 of sodium, to the nearest 5-milligram gram, the content may be expressed as increment when the serving contains 5 zero. to 140 milligrams of sodium, and to the (A) ‘‘Soluble fiber’’ (VOLUNTARY): nearest 10-milligram increment when A statement of the number of grams of

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soluble dietary fiber per serving may as the sum of saccharide derivatives in be declared voluntarily except when a which a hydroxyl group replaces a ke- claim is made on the label or in label- tone or aldehyde group and whose use ing about soluble fiber, label declara- in the food is listed by FDA (e.g., tion shall be required. Soluble fiber mannitol or xylitol) or is generally rec- content shall be indented under dietary ognized as safe (e.g., sorbitol). In lieu fiber and expressed to the nearest of the term ‘‘sugar alcohol,’’ the name gram, except that if a serving contains of the specific sugar alcohol (e.g., less than 1 gram, the statement ‘‘Con- ‘‘xylitol’’) present in the product may tains less than 1 gram’’ or ‘‘less than 1 be used in the nutrition label, provided gram’’ may be used as an alternative, that only one sugar alcohol is present and if the serving contains less than 0.5 in the product. Sugar alcohol content gram, the content may be expressed as shall be indented and expressed to the zero. nearest gram, except that if a serving (B) ‘‘Insoluble fiber’’ (VOLUNTARY): contains less than 1 gram, the state- A statement of the number of grams of ment ‘‘Contains less than 1 gram’’ or insoluble dietary fiber per serving may ‘‘less than 1 gram’’ may be used as an be declared voluntarily except when a alternative, and if the serving contains claim is made on the label or in label- less than 0.5 gram, the content may be ing about insoluble fiber, label declara- expressed as zero. tion shall be required. Insoluble fiber (iv) ‘‘Other carbohydrate’’ (VOL- content shall be indented under dietary UNTARY): A statement of the number fiber and expressed to the nearest of grams of other carbohydrate per gram, except that if a serving contains serving may be declared voluntarily. less than 1 gram, the statement ‘‘Con- Other carbohydrate shall be defined as tains less than 1 gram’’ or ‘‘less than 1 the difference between total carbo- gram’’ may be used as an alternative, hydrate and the sum of dietary fiber, and if the serving contains less than 0.5 sugars, and sugar alcohol, except that gram, the content may be expressed as if sugar alcohol is not declared (even if zero. present), it shall be defined as the dif- (ii) ‘‘Sugars’’: A statement of the ference between total carbohydrate and number of grams of sugars per serving, the sum of dietary fiber and sugars. except that label declaration of sugars Other carbohydrate content shall be in- content is not required for products dented and expressed to the nearest that contain less than 1 gram of sugars gram, except that if a serving contains per serving if no claims are made about less than 1 gram, the statement ‘‘Con- sweeteners, sugars, or sugar alcohol tains less than 1 gram’’ or ‘‘less than 1 content. Sugars shall be defined as the gram’’ may be used as an alternative, sum of all free mono- and disaccharides and if the serving contains less than 0.5 (such as glucose, fructose, lactose, and gram, the content may be expressed as sucrose). Sugars content shall be in- zero. dented and expressed to the nearest (7) ‘‘Protein’’: A statement of the gram, except that if a serving contains number of grams of protein per serving less than 1 gram, the statement ‘‘Con- expressed to the nearest gram, except tains less than 1 gram’’ or ‘‘less than 1 that if a serving contains less than 1 gram’’ may be used as an alternative, gram, the statement ‘‘Contains less and if the serving contains less than 0.5 than 1 gram’’ or ‘‘less than 1 gram’’ gram, the content may be expressed as may be used as an alternative, and if zero. the serving contains less than 0.5 gram, (iii) ‘‘Sugar alcohol’’ (VOLUNTARY): the content may be expressed as zero. A statement of the number of grams of When the protein in products rep- sugar alcohols per serving may be de- resented or purported to be for adults clared voluntarily on the label, except and children 4 or more years of age has that when a claim is made on the label a protein quality value that is a pro- or in labeling about sugar alcohol or tein digestibility-corrected amino acid sugars when sugar alcohols are present score of less than 20 expressed as a per- in the product, sugar alcohol content cent, or when the protein in a product shall be declared. For nutrition label- represented or purported to be for chil- ing purposes, sugar alcohols are defined dren greater than 1 but less than 4

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years of age has a protein quality value and children 1 or more years of age is that is a protein digestibility-corrected equal to the actual amount of protein amino acid score of less than 40 ex- (grams) per serving multiplied by the pressed as a percent, either of the fol- amino acid score corrected for protein lowing shall be placed adjacent to the digestibility. If the corrected score is declaration of protein content by above 1.00, then it shall be set at 1.00. weight: The statement ‘‘not a signifi- The protein digestibility-corrected cant source of protein,’’ or a listing amino acid score shall be determined aligned under the column headed by methods given in sections 5.4.1, 7.2.1, ‘‘Percent Daily Value’’ of the corrected and 8 in ‘‘Protein Quality Evaluation, amount of protein per serving, as de- Report of the Joint FAO/WHO Expert termined in paragraph (c)(7)(ii) of this Consultation on Protein Quality Eval- section, calculated as a percentage of uation,’’ Rome, 1990, which is incor- the Daily Reference Value (DRV) or porated by reference. Sections 5.4.1, Reference Daily Intake (RDI), as appro- 7.2.1, and 8 of the ‘‘Report of the Joint priate, for protein and expressed as per- FAO/WHO Expert Consultation on Pro- cent of Daily Value. When the protein tein Quality Evaluation,’’ as published quality in a product as measured by by the Food and Agriculture Organiza- the Protein Efficiency Ratio (PER) is tion of the United Nations/World less than 40 percent of the reference Health Organization, is incorporated as standard (casein) for a product rep- it exists on the date of approval. This resented or purported to be for infants, incorporation by reference was ap- the statement ‘‘not a significant source proved by the Director of the Federal of protein’’ shall be placed adjacent to Register in accordance with 5 U.S.C. the declaration of protein content. Pro- 552(a) and 1 CFR part 51. It is available tein content may be calculated on the for inspection at the office of the FSIS basis of the factor of 6.25 times the ni- trogen content of the food as deter- Docket Clerk, Room 3171, South Build- mined by appropriate methods of anal- ing, 14th and Independence Avenue, ysis in accordance with § 381.409(h), ex- SW., Washington, DC, or at the Na- cept when the procedure for a specific tional Archives and Records Adminis- food requires another factor. tration (NARA). For information on (i) A statement of the corrected the availability of this material at amount of protein per serving, as de- NARA, call 202–741–6030, or go to: http:// termined in paragraph (c)(7)(ii) of this www.archives.gov/federallregister/ section, calculated as a percentage of codeloflfederallregulations/ the RDI or DRV for protein, as appro- ibrllocations.html. Copies of the incor- priate, and expressed as percent of poration by reference are available Daily Value, may be placed on the from the Product Assessment Division, label, except that such a statement Regulatory Programs, Food Safety and shall be given if a protein claim is Inspection Service, U.S. Department of made for the product, or if the product Agriculture, Room 329, West End Court is represented or purported to be for in- Building, Washington, DC 20250–3700. fants or children under 4 years of age. For products represented or purported When such a declaration is provided, it to be for infants, the corrected amount shall be placed on the label adjacent to of protein (grams) per serving is equal the statement of grams of protein and to the actual amount of protein aligned under the column headed (grams) per serving multiplied by the ‘‘Percent Daily Value,’’ and expressed relative protein quality value. The rel- to the nearest whole percent. However, ative protein quality value shall be de- the percentage of the RDI for protein termined by dividing the subject prod- shall not be declared if the product is uct’s protein PER value by the PER represented or purported to be for in- value for casein. If the relative protein fants and the protein quality value is value is above 1.00, it shall be set at less than 40 percent of the reference 1.00. standard. (iii) For the purpose of labeling with (ii) The corrected amount of protein a percent of the DRV or RDI, a value of (grams) per serving for products rep- 50 grams of protein shall be the DRV resented or purported to be for adults for adults and children 4 or more years

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of age, and the RDI for protein for chil- gredient (i.e., component) in another dren less than 4 years of age, infants, product; or pregnant women, and lactating women (B) Included in a product solely for shall be 16 grams, 14 grams, 60 grams, technological purposes and declared and 65 grams, respectively. only in the ingredients statement. The (8) Vitamins and minerals: A state- declaration may also include any of the ment of the amount per serving of the other vitamins and minerals listed in vitamins and minerals as described in paragraph (c)(8)(iv) of this section this paragraph, calculated as a percent when they are naturally occurring in of the RDI and expressed as percent of the food. The additional vitamins and Daily Value. minerals shall be listed in the order es- (i) For purposes of declaration of per- tablished in paragraph (c)(8)(iv) of this cent of Daily Value as provided for in section. paragraphs (d) through (g) of this sec- (iii) The percentages for vitamins tion, products represented or purported and minerals shall be expressed to the to be for use by infants, children less nearest 2-percent increment up to and than 4 years of age, pregnant women, including the 10-percent level, the or lactating women shall use the RDI’s nearest 5-percent increment above 10 that are specified for the intended percent and up to and including the 50- group. For products represented or pur- percent level, and the nearest 10-per- ported to be for use by both infants and cent increment above the 50-percent children under 4 years of age, the per- level. Amounts of vitamins and min- cent of Daily Value shall be presented erals present at less than 2 percent of by separate declarations according to the RDI are not required to be declared paragraph (e) of this section based on in nutrition labeling but may be de- the RDI values for infants from birth clared by a zero or by the use of an as- to 12 months of age and for children terisk (or other symbol) that refers to under 4 years of age. Similarly, the another asterisk (or symbol) that is percent of Daily Value based on both placed at the bottom of the table and the RDI values for pregnant women that is followed by the statement and for lactating women shall be de- ‘‘Contains less than 2 percent of the clared separately on products rep- Daily Value of this (these) nutrient resented or purported to be for use by (nutrients).’’ Alternatively, if vitamin both pregnant and lactating women. A, vitamin C, calcium, or iron is When such dual declaration is used on present in amounts less than 2 percent any label, it shall be included in all la- of the RDI, label declaration of the nu- beling, and equal prominence shall be trient(s) is not required if the state- given to both values in all such label- ment ‘‘Not a significant source of ing. All other products shall use the llll (listing the vitamins or min- RDI for adults and children 4 or more erals omitted)’’ is placed at the bottom years of age. of the table of nutrient values. (ii) The declaration of vitamins and (iv) The following RDI’s and nomen- minerals as a percent of the RDI shall clature are established for the fol- include vitamin A, vitamin C, calcium, lowing vitamins and minerals which and iron, in that order, and shall in- are essential in human nutrition: clude any of the other vitamins and Vitamin A, 5,000 International Units minerals listed in paragraph (c)(8)(iv) Vitamin C, 60 milligrams of this section when they are added, or Calcium, 1.0 gram when a claim is made about them. Iron, 18 milligrams Vitamin D, 400 International Units Other vitamins and minerals need not Vitamin E, 30 International Units be declared if neither the nutrient nor Thiamin, 1.5 milligrams the component is otherwise referred to Riboflavin, 1.7 milligrams on the label or in labeling or adver- Niacin, 20 milligrams tising and the vitamins and minerals Vitamin B6, 2.0 milligrams are: Folate, 0.4 milligram Vitamin B12, 6 micrograms (A) Required or permitted in a stand- Biotin, 0.3 milligram ardized food (e.g., thiamin, riboflavin, Pantothenic acid, 10 milligrams and niacin in enriched flour) and that Phosphorus, 1.0 gram standardized food is included as an in- Iodine, 150 micrograms

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Magnesium, 400 milligrams that have a total surface area available Zinc, 15 milligrams to bear labeling of 40 or less square Copper, 2.0 milligrams inches as provided for in paragraph (g) (v) The following synonyms may be of this section. added in parenthesis immediately fol- (i) The nutrition information shall be lowing the name of the nutrient or die- set off in a box by use of hairlines and tary component: shall be all black or one color type, printed on a white or other neutral Vitamin C—Ascorbic acid contrasting background whenever prac- Thiamin—Vitamin B 1 tical. Riboflavin—Vitamin B2 Folate—Folacin (ii) All information within the nutri- Calories—Energy tion label shall utilize: (A) A single easy-to-read type style, (vi) A statement of the percent of vi- (B) Upper and lower case letters, tamin A that is present as beta-caro- (C) At least one point leading (i.e., tene may be declared voluntarily. space between two lines of text) except When the vitamins and minerals are that at least four points leading shall listed in a single column, the state- be utilized for the information required ment shall be indented under the infor- by paragraphs (d)(7) and (d)(8) of this mation on vitamin A. When vitamins section, and and minerals are arrayed horizontally, (D) Letters should never touch. the statement of percent shall be pre- (iii) Information required in para- sented in parenthesis following the dec- graphs (d)(3), (d)(5), (d)(7), and (d)(8) of laration of vitamin A and the percent this section shall be in type size no of Daily Value of vitamin A in the smaller than 8 point. Except for the product (e.g., ‘‘Percent Daily Value: heading ‘‘Nutrition Facts,’’ the infor- Vitamin A 50 (90 percent as beta-caro- mation required in paragraphs (d)(4), tene)’’). When declared, the percent- (d)(6), and (d)(9) of this section and all ages shall be expressed in the same in- other information contained within the crements as are provided for vitamins nutrition label shall be in type size no and minerals in paragraph (c)(8)(iii) of smaller than 6 point. When provided, this section. the information described in paragraph (9) For the purpose of labeling with a (d)(10) of this section shall also be in percent of the DRV, the following type no smaller than 6 point. DRV’s are established for the following (iv) The headings required by para- food components based on the reference graphs (d)(2), (d)(4), and (d)(6) of this caloric intake of 2,000 calories: section (i.e., ‘‘Nutrition Facts,’’ Food component Unit of measurement DRV ‘‘Amount Per Serving,’’ and ‘‘% Daily Value*’’), the names of all nutrients Fat ...... grams (g) ...... 65 that are not indented according to re- Saturated fatty acids ...... do ...... 20 Cholesterol ...... milligrams (mg) ...... 300 quirements of paragraph (c) of this sec- Total carbohydrate ...... grams (g) ...... 300 tion (i.e., Calories, Total fat, Choles- Fiber ...... do ...... 25 terol, Sodium, Potassium, Total carbo- Sodium ...... milligrams (mg) ...... 2400 Potassium ...... do ...... 3500 hydrate, and Protein), and the percent- Protein ...... grams (g) ...... 50 age amounts required by paragraph (d)(7)(ii) of this section shall be high- (d)(1) Nutrient information specified lighted by bold or extra bold type or in paragraph (c) of this section shall be other highlighting (reverse printing is presented on products in the following not permitted as a form of high- format, except on products on which lighting) that prominently distin- dual columns of nutrition information guishes it from other information. No are declared as provided for in para- other information shall be highlighted. graph (e) of this section, on those prod- (v) A hairline rule that is centered ucts on which the simplified format is between the lines of text shall separate permitted to be used as provided for in ‘‘Amount Per Serving’’ from the cal- paragraph (f) of this section, on prod- orie statements required in paragraph ucts for infants and children less than (d)(5) of this section and shall separate 4 years of age as provided for in each nutrient and its corresponding § 381.500(c), and on products in packages percent of Daily Value required in

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paragraphs (d)(7)(i) and (d)(7)(ii) of this formation for both mandatory and any section from the nutrient and percent voluntary nutrients listed in paragraph of Daily Value above and below it. (c) of this section that are to be de- (2) The information shall be pre- clared in the nutrition label, except vi- sented under the identifying heading of tamins and minerals, shall be declared ‘‘Nutrition Facts’’ which shall be set in as follows: a type size larger than all other print (i) The name of each nutrient, as size in the nutrition label and, except specified in paragraph (c) of this sec- for labels presented according to the tion, shall be given in a column and format provided for in paragraph (d)(11) followed immediately by the quan- of this section, unless impractical, titative amount by weight for that nu- shall be set the full width of the infor- trient appended with a ‘‘g’’ for grams mation provided under paragraph (d)(7) or ‘‘mg’’ for milligrams. of this section. (ii) A listing of the percent of the (3) Information on serving size shall DRV as established in paragraphs immediately follow the heading. Such (c)(7)(iii) and (c)(9) of this section shall information shall include: be given in a column aligned under the (i) ‘‘Serving Size’’: A statement of heading ‘‘% Daily Value’’ established the serving size as specified in para- in paragraph (d)(6) of this section with graph (b)(9) of this section. the percent expressed to the nearest (ii) ‘‘Servings Per Container’’: The whole percent for each nutrient de- number of servings per container, ex- clared in the column described in para- cept that this statement is not re- graph (d)(7)(i) of this section for which quired on single-serving containers as a DRV has been established, except defined in paragraph (b)(8) of this sec- that the percent for protein may be tion or on single-ingredient, raw poul- omitted as provided in paragraph (c)(7) try products that are not ground or of this section. The percent shall be chopped poultry products described in calculated by dividing either the § 381.401. amount declared on the label for each (4) A subheading ‘‘Amount Per Serv- nutrient or the actual amount of each ing’’ shall be separated from serving nutrient (i.e., before rounding) by the size information by a bar. DRV for the nutrient, except that the (5) Information on calories shall im- percent for protein shall be calculated mediately follow the heading ‘‘Amount as specified in paragraph (c)(7)(ii) of Per Serving’’ and shall be declared in this section. The numerical value shall one line, leaving sufficient space be- be followed by the symbol for percent tween the declaration of ‘‘Calories’’ and ‘‘Calories from fat’’ to allow clear (i.e., %). differentiation, or, if ‘‘Calories from (8) Nutrient information for vitamins saturated fat’’ is declared, in a column and minerals shall be separated from with total ‘‘Calories’’ at the top, fol- information on other nutrients by a lowed by ‘‘Calories from fat’’ (in- bar and shall be arrayed horizontally dented), and ‘‘Calories from saturated (e.g., Vitamin A 4%, Vitamin C 2%, fat’’ (indented). Calcium 15%, Iron 4%) or may be listed (6) The column heading ‘‘% Daily in two columns, except that when more Value,’’ followed by an asterisk (e.g., than four vitamins and minerals are ‘‘% Daily Value*’’), shall be separated declared, they may be declared from information on calories by a bar. vertically with percentages listed The position of this column heading under the column headed ‘‘% Daily shall allow for a list of nutrient names Value.’’ and amounts as described in paragraph (9) A footnote, preceded by an aster- (d)(7) of this section to be to the left of, isk, shall be placed beneath the list of and below, this column heading. The vitamins and minerals and shall be sep- column heading ‘‘Percent Daily arated from that list by a hairline. Value,’’ ‘‘Percent DV,’’ or ‘‘% DV’’ may (i) The footnote shall state: Percent be substituted for ‘‘% Daily Value.’’ Daily Values are based on a 2,000 cal- (7) Except as provided for in para- orie diet. Your daily values may be graph (g) of this section, and except as higher or lower depending on your cal- permitted by § 381.500(d)(2), nutrient in- orie needs.

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Calories 2,000 2,500 right of the column required in paragraph (d)(7)(ii) of this section and set Total fat ...... Less than ...... 65 g 80 g Saturated fat ... Less than ...... 20 g 25 g off by a line that distinguishes it and Cholesterol ...... Less than ...... 300 mg 300 mg sets it apart from the percent of Daily Sodium ...... Less than ...... 2400 mg 2400 mg Value information. The caloric conver- Total carbo- ...... 300 g 375 g hydrate. sion information provided for in para- Dietary fiber ...... 25 g 30 g graph (d)(10) of this section may be presented beneath either side or along the (ii) If the percent of Daily Value is full length of the nutrition label. given for protein in the Percent of (ii) If the space beneath the manda- Daily Value column as provided in tory declaration of iron is not adequate paragraph (d)(7)(ii) of this section, pro- to accommodate any remaining vita- tein shall be listed under dietary fiber, mins and minerals to be declared or the and a value of 50 g shall be inserted on information required in paragraph the same line in the column headed (d)(9) of this section, the remaining in- ‘‘2,000’’ and value of 65 g in the column formation may be moved to the right headed ‘‘2,500.’’ and set off by a line that distinguishes (iii) If potassium is declared in the it and sets it apart from the percent of column described in paragraph (d)(7)(i) Daily Value information given to the of this section, potassium shall be list- left. The caloric conversion informa- ed under sodium and the DRV estab- tion provided for in paragraph (d)(10) of lished in paragraph (c)(9) of this section shall be inserted on the same line this section may be presented beneath in the numeric columns. either side or along the full length of (iv) The abbreviations established in the nutrition label. paragraph (g)(2) of this section may be (iii) If there is not sufficient contin- used within the footnote. uous vertical space (i.e., approximately (10) Caloric conversion information 3 inches) to accommodate the required on a per-gram basis for fat, carbo- components of the nutrition label up to hydrate, and protein may be presented and including the mandatory declara- beneath the information required in tion of iron, the nutrition label may be paragraph (d)(9), separated from that presented in a tabular display in which information by a hairline. This infor- the footnote required by paragraph mation may be presented horizontally (d)(9) of the section is given to the far (i.e., ‘‘Calories per gram: Fat 9, Carbo- right of the label, and additional vita- hydrate 4, Protein 4’’) or vertically in mins and minerals beyond the four columns. that are required (i.e., vitamin A, vita- (11)(i) If the space beneath the infor- min C, calcium, and iron) are arrayed mation on vitamins and minerals is not horizontally following declarations of adequate to accommodate the informa- the required vitamins and minerals. tion required in paragraph (d)(9) of this (12) The following sample label illus- section, the information required in trates the provisions of paragraph (d) paragraph (d)(9) may be moved to the of this section:

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(13)(i) Nutrition labeling on the outer changeably for the same type of food label of packages of poultry products (e.g., poultry salad containers) may use that contain two or more products in an aggregate display. the same packages (e.g., variety packs) (ii) Aggregate displays shall comply or of packages that are used inter- with format requirements of paragraph

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(d) of this section to the maximum ex- (d)(5) of this section with quantitative tent possible, except that the identity amounts declared in columns aligned of each food shall be specified to the under the column headings set forth in right of the ‘‘Nutrition Facts’’ title, paragraph (e)(1) of this section. and both the quantitative amount by (3) Quantitative information by weight (i.e., g/mg amounts) and the weight required in paragraph (d)(7)(i) of percent Daily Value for each nutrient this section shall be specified for the shall be listed in separate columns form of the product as packaged, but under the name of each food. may be on the basis of ’as consumed’ (14) When nutrition labeling appears for single-ingredient, raw poultry prod- in a second language, the nutrition in- ucts that are not ground or chopped formation may be presented in a sepa- poultry products described in § 381.401, rate nutrition label for each language and according to the label serving size or in one nutrition label with the infor- based on the Reference Amount in mation in the second language fol- § 381.412(b). lowing that in English. Numeric char- acters that are identical in both lan- (i) Quantitative information by guages need not be repeated (e.g., weight may be included for other forms ‘‘Protein/Proteinas 2 g’’). All required of the product represented by the addi- information must be included in both tional column(s) either immediately languages. adjacent to the required quantitative (e) Nutrition information may be pre- information by weight for the product sented for two or more forms of the as packaged, but may be on the basis of same product (e.g., both ‘‘raw’’ and ’as consumed’ for single-ingredient, ‘‘cooked’’) or for common combina- raw poultry products that are not tions of foods as provided for in para- ground or chopped poultry products de- graph (b) of this section, or for dif- scribed in § 381.401, and according to the ferent units (e.g., per 100 grams) as pro- label serving size based on the Ref- vided for in paragraph (b) of this sec- erence Amount in § 381.412(b) or as a tion, or for two or more groups for footnote. which RDI’s are established (e.g., both (A) If such additional quantitative infants and children less than 4 years information is given immediately adja- of age) as provided for in paragraph cent to the required quantitative infor- (c)(8)(i) of this section. When such dual mation, it shall be declared for all nu- labeling is provided, equal prominence trients listed and placed immediately shall be given to both sets of values. following and differentiated from the Information shall be presented in a for- required quantitative information mat consistent with paragraph (d) of (e.g., separated by a comma). Such in- this section, except that: formation shall not be put in a sepa- (1) Following the subheading of rate column. ‘‘Amount Per Serving,’’ there shall be (B) If such additional quantitative in- two or more column headings accurately describing the forms of the same formation is given in a footnote, it product (e.g., ‘‘raw’’ and ‘‘roasted’’), shall be declared in the same order as the combinations of foods, the units, or the nutrients are listed in the nutri- the RDI groups that are being declared. tion label. The additional quantitative The column representing the product information may state the total nutri- as packaged and according to the label ent content of the product identified in serving size based on the Reference the second column or the nutrient Amount in § 381.412(b) shall be to the amounts added to the product as pack- left of the numeric columns. aged, but may be on the basis of ’as (2) When the dual labeling is pre- consumed’ for single-ingredient, raw sented for two or more forms of the poultry products that are not ground same product, for combinations of or chopped poultry products described foods, or for different units, total cal- in § 381.401, for only those nutrients ories and calories from fat (and cal- that are present in different amounts ories from saturated fat, when de- than the amounts declared in the re- clared) shall be listed in a column and quired quantitative information. The indented as specified in paragraph footnote shall clearly identify which

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amounts are declared. Any subcompo- form(s) of the product for which quan- nents declared shall be listed par- titative information is presented. enthetically after principal compo- (4) Information required in para- nents (e.g., 1⁄2 cup skim milk contrib- graphs (d)(7)(ii) and (d)(8) of this sec- utes an additional 40 calories, 65 mg so- tion shall be presented under the sub- dium, 6 g total carbohydrate (6 g sug- heading ‘‘% DAILY VALUE’’ and in ars), and 4 g protein). columns directly under the column (ii) Total fat and its quantitative headings set forth in paragraph (e)(1) of amount by weight shall be followed by this section. an asterisk (or other symbol) (e.g., ‘‘Total fat (2 g)*’’) referring to another (5) The following sample label illus- asterisk (or symbol) at the bottom of trates the provisions of paragraph (e) the nutrition label identifying the of this section:

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(f)(1) Nutrition information may be (i.e., calories, total fat, sodium, total presented in a simplified format as set carbohydrate, and protein), are present forth herein when any required nutri- in insignificant amounts. An insignifi- ents, other than the core nutrients cant amount shall be defined as that

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amount that may be rounded to zero in (g) Foods in packages that have a nutrition labeling, except that for total total surface area available to bear la- carbohydrate, dietary fiber, sugars and beling of 40 or less square inches may protein, it shall be an amount less than modify the requirements of paragraphs 1 gram. (c) through (f) of this section and (2) The simplified format shall in- § 381.402(a) by one or more of the fol- clude information on the following nu- lowing means: trients: (1)(i) Presenting the required nutri- (i) Total calories, total fat, total car- tion information in a tabular or linear bohydrate, sodium, and protein; (i.e., string) fashion, rather than in (ii) Any of the following that are vertical columns if the product has a present in more than insignificant total surface area available to bear la- amounts: Calories from fat, saturated beling of less than 12 square inches, or fat, cholesterol, dietary fiber, sugars, if the product has a total surface area vitamin A, vitamin C, calcium, and available to bear labeling of 40 or less iron; and square inches and the package shape or (iii) Any vitamins and minerals list- size cannot accommodate a standard ed in paragraph (c)(8)(iv) of this section vertical column or tabular display on when they are added in fortified or fab- any label panel. Nutrition information ricated foods. may be given in a linear fashion only if (3) Other nutrients that are naturally the package shape or size will not ac- present in the product in more than in- commodate a tabular display. significant amounts may be volun- (ii) When nutrition information is tarily declared as part of the simplified given in a linear display, the nutrition format. information shall be set off in a box by (4) Any required nutrient, other than the use of a hairline. The percent Daily a core nutrient, that is present in an Value is separated from the quan- insignificant amount may be omitted titative amount declaration by the use from the tabular listing, provided that of parenthesis, and all nutrients, both the following statement is included at principal components and subcompo- the bottom of the nutrition label, ‘‘Not nents, are treated similarly. Bolding is a significant source of llll.’’ The required only on the title ‘‘Nutrition blank shall be filled in with the appro- Facts’’ and is allowed for nutrient priate nutrient or food component. Al- names for ‘‘Calories,’’ ‘‘Total fat,’’ ternatively, amounts of vitamins and ‘‘Cholesterol,’’ ‘‘Sodium,’’ ‘‘Total car- minerals present in insignificant bohydrate,’’ and ‘‘Protein.’’ amounts may be declared by the use of (2) Using any of the following abbre- an asterisk (or symbol) that is placed viations: at the bottom of the table of nutrient values and that is followed by the Serving size—Serv size Servings per container—Servings statement ‘‘Contains less than 2 per- Calories from fat—Fat cal cent of the Daily Value of this (these) Calories from saturated fat—Sat fat cal nutrient (nutrients).’’ Saturated fat—Sat fat (5) Except as provided for in para- Monounsaturated fat—Monounsat fat graph (g) of this section and in Polyunsaturated fat—Polyunsat fat § 381.500(c) and (d), nutrient informa- Cholesterol—Cholest tion declared in the simplified format Total carbohydrate—Total carb shall be presented in the same manner Dietary fiber—Fiber as specified in paragraphs (d) or (e) of Soluble fiber—Sol fiber this section, except that the footnote Insoluble fiber—Insol fiber required in paragraph (d)(9) of this sec- Sugar alcohol—Sugar alc tion is not required. When the footnote Other carbohydrate—Other carb is omitted, an asterisk shall be placed (3) Omitting the footnote required in at the bottom of the label followed by paragraph (d)(9) of this section and the statement ‘‘Percent Daily Values placing another asterisk at the bottom are based on a 2,000 calorie diet’’ and, if of the label followed by the statement the term ‘‘Daily Value’’ is not spelled ‘‘Percent Daily Values are based on a out in the heading, a statement that 2,000 calorie diet’’ and, if the term ‘‘DV’’ represents ‘‘Daily Value.’’ ‘‘Daily Value’’ is not spelled out in the

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heading, a statement that ‘‘DV’’ rep- available for inspection at the National resents ‘‘Daily Value.’’ Archives and Records Administration (4) Presenting the required informa- (NARA). For information on the avail- tion on any other label panel. ability of this material at NARA, call (h) Compliance with this section 202–741–6030, or go to: http:// shall be determined as follows: www.archives.gov/federallregister/ (1) A production lot is a set of food codeloflfederallregulations/ production consumer units that are ibrllocations.html. from one production shift. Alter- (3) Two classes of nutrients are de- natively, a collection of consumer fined for purposes of compliance: units of the same size, type, and style (i) Class I. Added nutrients in for- produced under conditions as nearly tified or fabricated foods; and uniform as possible, designated by a (ii) Class II. Naturally occurring (in- common container code or marking, digenous) nutrients. If any ingredient constitutes a production lot. which contains a naturally occurring (2) The sample for nutrient analysis (indigenous) nutrient is added to a shall consist of a composite of a min- food, the total amount of such nutrient imum of six consumer units, each from in the final food product is subject to a production lot. Alternatively, the Class II requirements unless the same sample for nutrient analysis shall con- nutrient is also added, which would sist of a composite of a minimum of six make the total amount of such nutri- consumer units, each randomly chosen ent subject to Class I requirements. to be representative of a production (4) A product with a label declaration lot. In each case, the units may be indi- of a vitamin, mineral, protein, total vidually analyzed and the results of the carbohydrate, dietary fiber, other car- analyses averaged, or the units would bohydrate, polyunsaturated or be composited and the composite ana- monounsaturated fat, or potassium lyzed. In both cases, the results, wheth- shall be deemed to be misbranded er an average or a single result from a under section 4(h) of the Poultry Prod- composite, will be considered by the ucts Inspection Act (21 U.S.C. 453(h)(4)) Agency to be the nutrient content of a unless it meets the following require- composite. All analyses shall be per- ments: formed by appropriate methods and (i) Class I vitamin, mineral, protein, procedures used by the Department for dietary fiber, or potassium. The nutri- each nutrient in accordance with the ent content of the composite is at least ‘‘Chemistry Laboratory Guidebook,’’ equal to the value for that nutrient de- or, if no USDA method is available and clared on the label. appropriate for the nutrient, by appro- (ii) Class II vitamin, mineral, propriate methods for the nutrient in ac- tein, total carbohydrate, dietary fiber, cordance with the 1990 edition of the other carbohydrate, polyunsaturated ‘‘Official Methods of Analysis’’ of the or monounsaturated fat, or potassium. AOAC International, formerly Associa- The nutrient content of the composite tion of Official Analytical Chemists, is at least equal to 80 percent of the 15th ed., which is incorporated by ref- value for that nutrient declared on the erence, unless a particular method of label; Provided, That no regulatory ac- analysis is specified in § 381.409(c), or, if tion will be based on a determination no USDA, AOAC, or specified method is of a nutrient value which falls below available and appropriate, by other re- this level by an amount less than the liable and appropriate analytical pro- variability generally recognized for the cedures as so determined by the Agen- analytical method used in that product cy. The ‘‘Official Methods of Analysis’’ at the level involved, and inherent nu- is incorporated as it exists on the date trient variation in a product. of approval. This incorporation by ref- (5) A product with a label declaration erence was approved by the Director of of calories, sugars, total fat, saturated the Federal Register in accordance fat, cholesterol, or sodium shall be with 5 U.S.C. 552(a) and 1 CFR part 51. deemed to be misbranded under section Copies may be purchased from the 4(h) of the Poultry Products Inspection AOAC International, 2200 Wilson Blvd., Act (21 U.S.C. 453(h)(4)) if the nutrient Suite 400, Arlington, VA 22201. It is also content of the composite is greater

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than 20 percent in excess of the value §§ 381.410–381.411 [Reserved] for that nutrient declared on the label; Provided, That no regulatory action § 381.412 Reference amounts custom- will be based on a determination of a arily consumed per eating occasion. nutrient value which falls above this (a) The general principles followed in level by an amount less than the varia- arriving at the reference amounts cus- bility generally recognized for the ana- tomarily consumed per eating occasion lytical method used in that product at (Reference Amount(s)), as set forth in the level involved, and inherent nutri- paragraph (b) of this section, are: ent variation in a product. (1) The Reference Amounts are cal- (6) The amount of a vitamin, mineral, culated for persons 4 years of age or protein, total carbohydrate, dietary older to reflect the amount of food cus- fiber, other carbohydrate, polyunsat- tomarily consumed per eating occasion urated or monounsaturated fat, or po- by persons in this population group. tassium may vary over labeled These Reference Amounts are based on amounts within good manufacturing data set forth in appropriate national practice. The amount of calories, sug- food consumption surveys. ars, total fat, saturated fat, choles- (2) The Reference Amounts are cal- terol, or sodium may vary under la- culated for an infant or child under 4 beled amounts within good manufac- years of age to reflect the amount of food customarily consumed per eating turing practice. occasion by infants up to 12 months of (7) Compliance will be based on the age or by children 1 through 3 years of metric measure specified in the label age, respectively. These Reference statement of serving size. Amounts are based on data set forth in (8) The management of the establish- appropriate national food consumption ment must maintain records to support surveys. Such Reference Amounts are the validity of nutrient declarations to be used only when the product is contained on product labels. Such specially formulated or processed for records shall be made available to the use by an infant or by a child under 4 inspector or any duly authorized rep- years of age. resentative of the Agency upon re- (3) An appropriate national food con- quest. sumption survey includes a large sam- (9) The compliance provisions set ple size representative of the demo- forth in paragraph (h)(1) through (8) of graphic and socioeconomic characteris- this section shall not apply to single- tics of the relevant population group ingredient, raw poultry products that and must be based on consumption are not ground or chopped poultry data under actual conditions of use. products described in § 381.401, includ- (4) To determine the amount of food ing those that have been previously customarily consumed per eating occa- frozen, when nutrition labeling is based sion, the mean, median, and mode of on the most current representative the consumed amount per eating occa- data base values contained in USDA’s sion were considered. National Nutrient Data Bank or its re- (5) When survey data were insuffi- leased form, the USDA National Nutri- cient, FSIS took various other sources ent Database for Standard Reference, of information on serving sizes of food into consideration. These other sources as provided in § 381.445(e) and (f). of information included: (Paperwork requirements were approved by (i) Serving sizes used in dietary guid- the Office of Management and Budget under ance recommendations or rec- control number 0583–0088.) ommended by other authoritative sys- [58 FR 675, Jan. 6, 1993; 58 FR 43788, Aug. 18, tems or organizations; 1993, as amended at 58 FR 47628, Sept. 10, (ii) Serving sizes recommended in 1993; 59 FR 45196, Sept. 1, 1994; 60 FR 197, Jan. comments; 3, 1995; 60 FR 10304, Feb. 24, 1995; 69 FR 58802, (iii) Serving sizes used by manufac- Oct. 1, 2004; 75 FR 82166, Dec. 29, 2010] turers and grocers; and (iv) Serving sizes used by other countries.

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(6) Because they reflect the amount as the basis for determining serving customarily consumed, the Reference sizes for specific products: Amount and, in turn, the serving size declared on the product label are based TABLE 1—REFERENCE AMOUNTS CUSTOMARILY on only the edible portion of food, and CONSUMED PER EATING OCCASION—INFANT not bone, seed, shell, or other inedible AND TODDLER FOODS 123 components. Reference (7) The Reference Amount is based on Product category amount the major intended use of the product (e.g., a mixed dish measurable with a Infant & Toddler Foods: Dinner Dry Mix ...... 15 g cup as a main dish and not as a side Dinner, ready-to-serve, strained type ...... 60 g dish). Dinner, soups, ready-to-serve junior type .... 110 g (8) The Reference Amounts for prod- Dinner, stew or soup ready-to-serve tod- ucts that are consumed as an ingre- dlers ...... 170 g Plain poultry and poultry sticks, ready-to- dient of other products, but that may serve ...... 55 g also be consumed in the form in which 1 These values represent the amount of food customarily they are purchased (e.g., ground poul- consumed per eating occasion and were primarily derived try), are based on use in the form pur- from the 1977–1978 and the 1987–1988 Nationwide Food Consumption Surveys conducted by the U.S. Department of chased. Agriculture. (9) FSIS sought to ensure that foods 2 Unless otherwise noted in the Reference Amount column, the Reference Amounts are for the ready-to-serve or almost that have similar dietary usage, prod- ready-to-serve form of the product (i.e., heat and serve). If not uct characteristics, and customarily listed separately, the Reference Amount for the unprepared form (e.g., dehydrated cereal) is the amount required to make consumed amounts have a uniform Ref- one Reference Amount of the prepared form. erence Amount. 3 Manufacturers are required to convert the Reference Amount to the label serving size in a household measure (b) The following Product Categories most appropriate to their specific product using the proce- and Reference Amounts shall be used dures established by the regulation.

TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION—GENERAL FOOD SUPPLY 12345

Reference Amount Reference Amount Product category Ready-to-serve Ready-to-cook

Egg mixtures, (western style omelet, souffle, egg foo young with poul- 110 g n/a try). Salad and potato toppers; e.g., poultry bacon bits ...... 7 g n/a Bacon; e.g., poultry breakfast strips...... 15 g 26 g = bacon. 18 g = breakfast strips Dried; e.g., poultry jerky, dried poultry, poultry sausage products with a 30 g n/a moisture/protein ratio of less than 2:1. Snacks; e.g., poultry snack food sticks ...... 30 g n/a Luncheon products, poultry bologna, poultry Canadian style bacon, 55 g n/a poultry crumbles, poultry luncheon loaf, potted poultry products, poultry taco filings. Linked poultry sausage products, poultry franks, poultry Polish sausage, 55 g n/a smoked or pickled poultry meat, poultry smoked sausage. 69 g = uncooked sausage. Entrees without sauce, poultry cuts, ready to cook poultry cuts, includ- 85 g 114g ing marinated, tenderized, injected cuts of poultry, poultry corn dogs, poultry croquettes, poultry fritters, cured poultry ham products, adult pureed poultry. Canned poultry, canned chicken, canned 4 turkey ...... 55 g n/a Entrees with sauce, turkey and gravy ...... 140 g n/a Mixed dishes NOT measurable with a cup; 5 e.g., poultry burrito, poultry 140 g (plus 55 g for prod- n/a enchiladas, poultry pizza, poultry quiche, all types of poultry sand- ucts toppings) wiches, cracker and poultry lunch-type packages, poultry gyro, poultry stromboli, poultry frank on a bun, poultry burger on a bun, poultry taco, chicken cordon bleu, poultry calzone, stuffed vegetables with poultry, poultry kabobs. Mixed dishes, measurables with a cup; e.g., poultry casserole, maca- 1 cup n/a roni and cheese with poultry, poultry pot pie, poultry spaghetti with sauce, poultry chili, poultry chili with beans, poultry hash, creamed dried poultry, poultry ravioli in sauce, poultry a la king, poultry stew, poultry goulash, poultry lasagna, poultry-filled pasta. Salads—pasta or potato, potato salad with poultry, macaroni and poul- 140 g n/a try salad. Salads—all other, poultry salads, chicken salad, turkey salad ...... 100 g n/a Soups—all varieties ...... 245 g n/a

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TABLE 2—REFERENCE AMOUNTS CUSTOMARILY CONSUMED PER EATING OCCASION—GENERAL FOOD SUPPLY 12345—Continued

Reference Amount Reference Amount Product category Ready-to-serve Ready-to-cook

Major main entree type sauce; e.g., spaghetti sauce with poultry ...... 125 g n/a Minor main entree sauce; e.g., pizza sauce with poultry, gravy ...... 1⁄4 cup n/a Seasoning mixes dry, freeze dry, dehydrated, concentrated soup mixes, bases, extracts, dried broths and stock/juice, freeze dry trail mix products with poultry. As reconstituted: Amount to make one Reference Amount of the final dish; e.g.— Gravy ...... 1⁄4 cup n/a Major main entree type sauce ...... 125 g n/a Soup ...... 245 g n/a Entree measurable with a cup ...... 1 cup n/a 1 These values represent the amount of food customarily consumed per eating occasion and were primarily derived from the 1977–78 and the 1987–88 Nationwide Food Consumption Surveys conducted by the U.S. Department of Agriculture. 2 Manufacturers are required to convert the Reference Amounts to the label serving size in a household measure most appropriate to their specific product using the procedures established by regulation. 3 Examples listed under Product Category are not all inclusive or exclusive. Examples are provided to assist manufacturers in identifying appropriate product Reference Amount. 4 If packed or canned in liquid, the Reference Amount is for the drained solids, except for products in which both the solids and liquids are customarily consumed. 5 Pizza sauce is part of the pizza and is not considered to be a sauce topping.

(c) For products that have no Ref- units, the weights of the appropriate erence Amount listed in paragraph (b) volumes should be used (e.g., grams of of this section for the unprepared or one ingredient plus gram weight of ta- the prepared form of the product and blespoons of a second ingredient). that consist of two or more foods pack- (d) If a product requires further prep- aged and presented to be consumed to- aration, e.g., cooking or the addition of gether (e.g., poultry lunch meat with water or other ingredients, and if para- cheese and crackers), the Reference graph (b) of this section provides a Ref- Amount for the combined product shall erence Amount for the product in the be determined using the following prepared form, then the Reference rules: Amount for the unprepared product (1) For bulk products, the Reference shall be determined using the following Amount for the combined product shall rules: be the Reference Amount, as estab- (1) Except as provided for in para- lished in paragraph (b) of this section, graph (d)(2) of this section, the Ref- for the ingredient that is represented erence Amount for the unprepared as the main ingredient plus propor- product shall be the amount of the un- tioned amounts of all minor ingredi- prepared product required to make the ents. Reference Amount for the prepared (2) For products where the ingredient product as established in paragraph (b) represented as the main ingredient is of this section. one or more discrete units, the Ref- (2) For products where the entire erence Amount for the combined prod- contents of the package is used to pre- uct shall be either the number of small pare one large discrete unit usually di- discrete units or the fraction of the vided for consumption, the Reference large discrete unit that is represented Amount for the unprepared product as the main ingredient that is closest shall be the amount of the unprepared to the Reference Amount for that in- product required to make the fraction gredient as established in paragraph (b) of the large discrete unit closest to the of this section plus proportioned Reference Amount for the prepared amounts of all minor ingredients. product as established in paragraph (b) (3) If the Reference Amounts are in of this section. compatible units, they shall be (e) The Reference Amount for an imi- summed (e.g., ingredients in equal vol- tation or substitute product or altered umes such as tablespoons). If the Ref- product as defined in § 381.413(d), such erence Amounts are in incompatible as a ‘‘low calorie’’ version, shall be the

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same as for the product for which it is with supporting documentation, sub- offered as a substitute. mitted to the Agency under this sec- (f) The Reference Amounts set forth tion will be governed by the rules spec- in paragraphs (b) through (e) of this ified in subchapter D, title 9. section shall be used in determining (4) Data accompanying the labeling whether a product meets the criteria application, such as food consumption for nutritional claims. If the serving data, shall be submitted on separate size declared on the product label dif- sheets, suitably identified. If such data fers from the Reference Amount, and has already been submitted with an the product meets the criteria for the earlier labeling application from the claim only on the basis of the Ref- applicant, the present labeling applica- erence Amount, the claim shall be fol- tion must provide the data. lowed by a statement that sets forth (5) The labeling application must be the basis on which the claim is made. signed by the applicant or by his or her That statement shall include the Ref- attorney or agent, or (if a corporation) erence Amount as it appears in para- by an authorized official. graph (b) of this section followed, in (6) The labeling application shall in- parenthesis, by the amount in common clude a statement signed by the person household measure if the Reference responsible for the labeling applica- Amount is expressed in measures other tion, that to the best of his or her than common household measures. knowledge, it is a representative and (g) The Administrator, on his or her balanced submission that includes un- own initiative or on behalf of any in- favorable information, as well as favor- terested person who has submitted a able information, known to him or her labeling application, may issue a pro- pertinent to the evaluation of the la- posal to establish or amend a Product beling application. Category or Reference Amount identi- (7) Labeling applications for a new fied in paragraph (b) of this section. Reference Amount and/or Product Cat- (1) Labeling applications and sup- egory shall be accompanied by the fol- porting documentation to be filed lowing data which shall be submitted under this section shall be submitted in the following form to the Director, in quadruplicate, except that the sup- Food Labeling Division, Regulatory porting documentation may be sub- Programs, Food Safety and Inspection mitted on a computer disc copy. If any Service, Washington, DC 20250: part of the material submitted is in a foreign language, it shall be accom- llllllllllllllllllllllll panied by an accurate and complete (Date) English translation. The labeling appli- The undersigned, llllll submits this cation shall state the applicant’s post labeling application pursuant to 9 CFR office address. 381.412 with respect to Reference Amount (2) Pertinent information will be con- and/or Product Category. sidered as part of an application on the Attached hereto, in quadruplicate, or on a basis of specific reference to such infor- computer disc copy, and constituting a part of this labeling application, are the fol- mation submitted to and retained in lowing: the files of the Food Safety and Inspec- (i) A statement of the objective of the lation Service. However, any reference to beling application; unpublished information furnished by a (ii) A description of the product; person other than the applicant will (iii) A complete sample product label in- not be considered unless use of such including nutrition label, using the format es- formation is authorized (with the un- tablished by regulation; derstanding that such information may (iv) A description of the form in which the in whole or part be subject to release product will be marketed; to the public) in a written statement (v) The intended dietary uses of the prod- signed by the person who submitted it. uct with the major use identified (e.g., turkey as a luncheon meat); Any reference to published information (vi) If the intended use is primarily as an should be accompanied by reprints or ingredient in other foods, list of foods or food photostatic copies of such references. categories in which the product will be used (3) The availability for public disclo- as an ingredient with information on the sure of labeling applications, along prioritization of the use;

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(vii) The population group for which the (A) Sampled population selected should be product will be offered for use (e.g., infants, representative of the demographic and socio- children under 4 years of age); economic characteristics of the target popu- (viii) The names of the most closely-relation group for which the food is intended. lated products (or in the case of foods for (B) Sample size (i.e., number of eaters) special dietary use and imitation or sub- should be large enough to give reliable esti- stitute foods, the names of the products for mates for customarily consumed amounts. which they are offered as substitutes); (C) The study protocol should identify po- (ix) The suggested Reference Amount (the tential biases and describe how potential bi- amount of edible portion of food as con- ases are controlled for or, if not possible to sumed, excluding bone, skin or other inedible control, how they affect interpretation of re- components) for the population group for sults. which the product is intended with full de- (D) The methodology used to collect or scription of the methodology and procedures process data including study design, sam- that were used to determine the suggested pling procedures, materials used (e.g., ques- Reference Amount. In determining the Ref- tionnaire, interviewer’s manual), procedures erence Amount, general principles and fac- used to collect or process data, methods or tors in paragraph (a) of this section should procedures used to control for unbiased esti- be followed. mates, and procedures used to correct for (x) The suggested Reference Amount shall nonresponse, should be fully documented. be expressed in metric units. Reference (xiii) A statement concerning the feasi- Amounts for foods shall be expressed in bility of convening associations, corpora- grams except when common household units tions, consumers, and other interested par- such as cups, tablespoons, and teaspoons are ties to engage in negotiated rulemaking to more appropriate or are more likely to pro- develop a proposed rule. mote uniformity in serving sizes declared on product labels. For example, common house- Yours very truly, hold measures would be more appropriate if Applicant lllllllllllllll products within the same category differ By lllllllllllllllllll substantially in density such as mixed dishes measurable with a cup. (Indicate authority) (A) In expressing the Reference Amount in (8) Upon receipt of the labeling appli- grams, the following general rules shall be cation and supporting documentation, followed: the applicant shall be notified, in writ- (1) For quantities greater than 10 grams, the quantity shall be expressed in nearest 5 ing, of the date on which the labeling grams increment. application was received. Such notice (2) For quantities less than 10 grams, exact shall inform the applicant that the la- gram weights shall be used. beling application is undergoing Agen- (B) [Reserved] cy review and that the applicant shall (xi) A labeling application for a new sub- subsequently be notified of the Agen- category of food with its own Reference cy’s decision to consider for further re- Amount shall include the following addi- view or deny the labeling application. tional information: (A) Data that demonstrate that the new (9) Upon review of the labeling appli- subcategory of food will be consumed in cation and supporting documentation, amounts that differ enough from the Ref- the Agency shall notify the applicant, erence Amount for the parent category to in writing, that the labeling applica- warrant a separate Reference Amount. Data tion is either being considered for fur- must include sample size, and the mean, ther review or that it has been sum- standard deviation, median, and modal con- marily denied by the Administrator. sumed amount per eating occasion for the product identified in the labeling application (10) If the labeling application is and for other products in the category. All summarily denied by the Adminis- data must be derived from the same survey trator, the written notification shall data. state the reasons therefor, including (B) Documentation supporting the dif- why the Agency has determined that ference in dietary usage and product charac- the proposed Reference Amount and/or teristics that affect the consumption size Product Category is false or mis- that distinguishes the product identified in leading. The notification letter shall the labeling application from the rest of the inform the applicant that the applicant products in the category. (xii) In conducting research to collect or may submit a written statement by process food consumption data in support of way of answer to the notification, and the labeling application, the following gen- that the applicant shall have the right eral guidelines should be followed. to request a hearing with respect to

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the merits or validity of the Adminis- ministrator, the Agency shall notify trator’s decision to deny the use of the the applicant, in writing, of the basis proposed Reference Amount and/or for the denial, including the reason Product Category. why the Reference Amount and/or (i) If the applicant fails to accept the Product Category on the labeling was determination of the Administrator determined by the Agency to be false and files an answer and requests a or misleading. The notification letter hearing, and the Administrator, after shall also inform the applicant that the review of the answer, determines the applicant may submit a written state- initial determination to be correct, the ment by way of answer to the notifica- Administrator shall file with the Hear- tion, and that the applicant shall have ing Clerk of the Department the notifi- the right to request a hearing with re- cation, answer, and the request for a spect to the merits or validity of the hearing, which shall constitute the complaint and answer in the pro- Administrator’s decision to deny the ceeding, which shall thereafter be con- use of the proposed Reference Amount ducted in accordance with the Depart- and/or Product Category. ment’s Uniform Rules of Practice. (A) If the applicant fails to accept (ii) The hearing shall be conducted the determination of the Adminis- before an administrative law judge trator and files an answer and requests with the opportunity for appeal to the a hearing, and the Administrator, after Department’s Judicial Officer, who review of the answer, determines the shall make the final determination for initial determination to be correct, the the Secretary. Any such determination Administrator shall file with the Hear- by the Secretary shall be conclusive ing Clerk of the Department the notifi- unless, within 30 days after receipt of cation, answer, and the request for a notice of such final determination, the hearing, which shall constitute the applicant appeals to the United States complaint and answer in the pro- Court of Appeals for the circuit in ceeding, which shall thereafter be con- which the applicant has its principal ducted in accordance with the Depart- place of business or to the United ment’s Uniform Rules of Practice. States Court of Appeals for the District (B) The hearing shall be conducted of Columbia Circuit. before an administrative law judge (11) If the labeling application is not with the opportunity for appeal to the summarily denied by the Adminis- Department’s Judicial Officer, who trator, the Administrator shall publish shall make the final determination for in the FEDERAL REGISTER a proposed rule to amend the regulations to au- the Secretary. Any such determination thorize the use of the Reference by the Secretary shall be conclusive Amount and/or Product Category. The unless, within 30 days after receipt of proposal shall also summarize the la- notice of such final determination, the beling application, including where the applicant appeals to the United States supporting documentation can be re- Court of Appeals for the circuit in viewed. The Administrator’s proposed which the applicant has its principal rule shall seek comment from con- place of business or to the United sumers, the industry, consumer and in- States Court of Appeals for the District dustry groups, and other interested of Columbia. persons on the labeling application and (ii) If the Reference Amount and/or the use of the proposed Reference Product Category is approved, the Amount and/or Product Category. Agency shall notify the applicant, in After public comment has been re- writing, and shall also publish in the ceived and reviewed by the Agency, the FEDERAL REGISTER a final rule amend- Administrator shall make a determina- ing the regulations to authorize the tion on whether the proposed Reference Amount and/or Product Category shall be approved for use on the labeling of poultry products. (i) If the Reference Amount and/or Product Category is denied by the Ad-

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use of the Reference Amount and/or (c) Information that is required or Product Category. permitted by § 381.409 to be declared in nutrition labeling, and that appears as (Paperwork requirements were approved by part of the nutrition label, is not a nu- the Office of Management and Budget under control number 0583–0088.) trient content claim and is not subject to the requirements of this section. If [58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, such information is declared elsewhere 1993, as amended at 58 FR 47628, Sept. 10, on the label or in labeling, it is a nutri- 1993; 59 FR 45198, Sept. 1, 1994; 60 FR 207, Jan. 3, 1995] ent content claim and is subject to the requirements for nutrient content § 381.413 Nutrient content claims; gen- claims. eral principles. (d) A ‘‘substitute’’ product is one that may be used interchangeably with (a) This section applies to poultry another product that it resembles, i.e., products that are intended for human that it is organoleptically, physically, consumption and that are offered for and functionally (including shelf life) sale. similar to, and that it is not nutrition- (b) A claim which, expressly or by ally inferior to unless it is labeled as implication, characterizes the level of an ‘‘imitation.’’ a nutrient (nutrient content claim) of (1) If there is a difference in perform- the type required in nutrition labeling ance characteristics that materially pursuant to § 381.409, may not be made limits the use of the product, the prod- on a label or in labeling of that product uct may still be considered a substitute unless the claim is made in accordance if the label includes a disclaimer adja- with the applicable provisions in this cent to the most prominent claim as subpart. defined in paragraph (j)(2)(iii) of this (1) An expressed nutrient content section, informing the consumer of claim is any direct statement about such difference (e.g., ‘‘not rec- the level (or range) of a nutrient in the ommended for frying’’). product, e.g., ‘‘low sodium’’ or ‘‘con- (2) This disclaimer shall be in easily tains 100 calories.’’ legible print or type and in a size no (2) An implied nutrient content claim less than that required by § 381.121(c) is any claim that: for the net quantity of contents state- (i) Describes the product or an ingre- ment, except where the size of the dient therein in a manner that sug- claim is less than two times the re- gests that a nutrient is absent or quired size of the net quantity of con- present in a certain amount (e.g., tents statement, in which case the dis- ‘‘high in oat bran’’); or claimer statement shall be no less than (ii) Suggests that the product, be- one-half the size of the claim but no cause of its nutrient content, may be smaller than 1⁄16-inch minimum height, useful in maintaining healthy dietary except as permitted by § 381.500(d)(2). practices and is made in association (e)(1) Because the use of a ‘‘free’’ or with an explicit claim or statement ‘‘low’’ claim before the name of a prod- about a nutrient (e.g., ‘‘healthy, con- uct implies that the product differs tains 3 grams (g) of fat’’). from other products of the same type (3) Except for claims regarding vita- by virtue of its having a lower amount mins and minerals described in para- of the nutrient, only products that graph (q)(3) of this section, no nutrient have been specially processed, altered, content claims may be made on prod- formulated, or reformulated so as to ucts intended specifically for use by in- lower the amount of the nutrient in fants and children less than 2 years of the product, remove the nutrient from age unless the claim is specifically pro- the product, or not include the nutri- vided for in subpart Y of this part. ent in the product, may bear such a (4) Reasonable variations in the spell- claim (e.g., ‘‘low sodium chicken noo- ing of the terms defined in applicable dle soup’’). provisions in this subpart and their (2) Any claim for the absence of a nu- synonyms are permitted provided these trient in a product, or that a product is variations are not misleading (e.g., low in a nutrient when the product has ‘‘hi’’ or ‘‘lo’’). not been specially processed, altered,

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formulated, or reformulated to qualify the nutrient in the product and it is for that claim shall indicate that the not false or misleading in any respect product inherently meets the criteria (e.g., ‘‘100 calories’’ or ‘‘5 grams of and shall clearly refer to all products fat’’), in which case no disclaimer is re- of that type and not merely to the par- quired. ticular brand to which the labeling at- (4) ‘‘Percent fat free’’ claims are not taches (e.g., ‘‘chicken breast meat, a authorized by this paragraph. Such low sodium food’’). claims shall comply with § 381.462(b)(6). (f) A nutrient content claim shall be (j) A product may bear a statement in type size and style no larger than that compares the level of a nutrient in two times that of the statement of the product with the level of a nutrient identity and shall not be unduly promi- in a reference product. These state- nent in type style compared to the ments shall be known as ‘‘relative statement of identity. claims’’ and include ‘‘light,’’ ‘‘re- (g) Labeling information required in duced,’’ ‘‘less’’ (or ‘‘fewer’’), and §§ 381.413, 381.454, 381.456, 381.460, 381.461, ‘‘more’’ claims. 381.462, and 381.480, whose type size is (1) To bear a relative claim about the not otherwise specified, is required to level of a nutrient, the amount of that be in letters and/or numbers no less nutrient in the product must be com- than 1⁄16 inch in height, except as per- pared to an amount of nutrient in an mitted by § 381.500(d)(2). appropriate reference product as speci- (h) [Reserved] fied in this paragraph (j). (i) Except as provided in § 381.409 or in (i)(A) For ‘‘less’’ (or ‘‘fewer’’) and paragraph (q)(3) of this section, the ‘‘more’’ claims, the reference product label or labeling of a product may con- may be a dissimilar product within a tain a statement about the amount or product category that can generally be percentage of a nutrient if: substituted for one another in the diet (1) The use of the statement on the or a similar product. product implicitly characterizes the (B) For ‘‘light,’’ ‘‘reduced,’’ and level of the nutrient in the product and ‘‘added’’ claims, the reference product is consistent with a definition for a shall be a similar product, and claim, as provided in subpart Y of this (ii)(A) For ‘‘light’’ claims, the ref- part, for the nutrient that the label ad- erence product shall be representative dresses. Such a claim might be, ‘‘less of the type of product that includes the than 10 g of fat per serving;’’ product that bears the claim. The nu- (2) The use of the statement on the trient value for the reference product product implicitly characterizes the shall be representative of a broad base level of the nutrient in the product and of products of that type; e.g., a value in is not consistent with such a defini- a representative, valid data base; an tion, but the label carries a disclaimer average value determined from the top adjacent to the statement that the three national (or regional) brands, a product is not ‘‘low’’ in or a ‘‘good market basket norm; or, where its nu- source’’ of the nutrient, such as ‘‘only trient value is representative of the 200 milligrams (mg) sodium per serv- product type, a market leader. Firms ing, not a low sodium product.’’ The using such a reference nutrient value disclaimer must be in easily legible as a basis for a claim, are required to print or type and in a size no less than provide specific information upon required by § 381.121(c) for the net quan- which the nutrient value was derived, tity of contents, except where the size on request, to consumers and appro- of the claim is less than two times the priate regulatory officials. required size of the net quantity of (B) For relative claims other than contents statement, in which case the ‘‘light,’’ including ‘‘less’’ and ‘‘more’’ disclaimer statement shall be no less claims, the reference product may be than one-half the size of the claim but the same as that provided for ‘‘light’’ no smaller than 1⁄16-inch minimum in paragraph (j)(1)(ii)(A) of this section height, except as permitted by or it may be the manufacturer’s reg- § 381.500(d)(2); ular product, or that of another manu- (3) The statement does not in any facturer, that has been offered for sale way implicitly characterize the level of to the public on a regular basis for a

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substantial period of time in the same (C) A claim on the information panel; geographic area by the same business or entity or by one entitled to use its (D) A claim elsewhere on the label or trade name, provided the name of the labeling. competitor is not used on the labeling (iv) The label or labeling must also of the product. The nutrient values bear: used to determine the claim when com- (A) Clear and concise quantitative in- paring a single manufacturer’s product formation comparing the amount of to the labeled product shall be either the subject nutrient in the product per the values declared in nutrition label- labeled serving size with that in the ing or the actual nutrient values, pro- reference product; and vided that the resulting labeling is in- (B) This statement shall appear adja- ternally consistent (i.e., that the val- cent to the most prominent claim or to ues stated in the nutrition informa- the nutrition information. tion, the nutrient values in the accom- (3) A relative claim for decreased lev- panying information, and the declara- els of a nutrient may not be made on tion of the percentage of nutrient by the label or in labeling of a product if which the product has been modified the nutrient content of the reference are consistent and will not cause con- product meets the requirement for a sumer confusion when compared), and ‘‘low’’ claim for that nutrient. that the actual modification is at least equal to the percentage specified in the (k) The term ‘‘modified’’ may be used definition of the claim. in the statement of identity of a product that bears a relative claim that (2) For products bearing relative claims: complies with the requirements of this part, followed immediately by the (i) The label or labeling must state name of the nutrient whose content the identity of the reference product has been altered (e.g., ‘‘modified fat and the percent (or fraction) of the ‘product’ ’’). This statement of identity amount of the nutrient in the reference must be immediately followed by the product by which the nutrient has been comparative statement such as ‘‘con- modified, (e.g., ‘‘50 percent less fat tains 35 percent less fat than ‘reference than ‘reference product’ ’’ or ‘‘1⁄3 fewer product’ ’’ The label or labeling must calories than ‘reference product’ ’’); and also bear the information required by (ii) This information shall be imme- paragraph (j)(2) of this section in the diately adjacent to the most prominent manner prescribed. claim in easily legible boldface print or (l) For purposes of making a claim, a type, in distinct contrast to other ‘‘meal-type’’ product will be defined as printed or graphic matter, that is no a product that: less than that required by § 381.121(c) for net quantity of contents, except (1) Makes a major contribution to the where the size of the claim is less than diet by: two times the required size of the net (i) Weighing at least 10 ounces per la- quantity of contents statement, in beled serving; and which case the referral statement shall (ii) Containing not less than three 40 be no less than one-half the size of the gram portions of food, or combinations claim, but no smaller than 1⁄16-inch of foods, from two or more of the fol- minimum height, except as permitted lowing four food groups, except as by § 381.500(d)(2). noted in paragraph (l)(1)(ii)(E) of this (iii) The determination of which use section: of the claim is in the most prominent (A) Bread, cereal, rice, and pasta; location on the label or labeling will be (B) Fruits and vegetables; made based on the following factors, (C) Milk, yogurt, and cheese; considered in order: (D) Meat, poultry, fish, dry beans, (A) A claim on the principal display eggs, and nuts; except that: panel adjacent to the statement of (E) These foods will not be sauces identity; (except for foods in the four food (B) A claim elsewhere on the prin- groups in paragraph (l)(1)(ii)(A) cipal display panel; through (D) of this section, that are in

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the sauces), gravies, condiments, rel- § 381.412(f) (e.g., ‘‘very low sodium, 35 ishes, pickles, olives, jams, jellies, syr- mg or less per 55 grams’’). ups, breadings, or garnishes; and (2) The criteria for the claim shall be (2) Is represented as, or is in the form immediately adjacent to the most commonly understood to be, a break- prominent claim in easily legible print fast, lunch, dinner, meal, or entre`e. or type and in a size that is no less Such representations may be made by than that required by § 381.121(c) for net statements, photographs, or vignettes. quantity of contents, except where the (m) For purposes of making a claim, size of the claim is less than two times a ‘‘main-dish’’ product will be defined the required size of the net quantity of as a food that: contents statement, in which case the (1) Makes a major contribution to the criteria statement shall be no less than meal by: (i) Weighing at least 6 ounces per la- one-half the size of the claim but no beled serving; and smaller than 1/16-inch minimum (ii) Containing not less than 40 grams height, except as permitted by of food, or combinations of foods, from § 381.500(d)(2). two or more of the following four food (q) The following exemptions apply: groups, except as noted in paragraph (1) Nutrient content claims that have (m)(1)Iii)(E) of this section. not been defined by regulation and that (A) Bread, cereal, rice, and pasta; appear as part of a brand name that (B) Fruits and vegetables; was in use prior to November 27, 1991, (C) Milk, yogurt, and cheese; may continue to be used as part of that (D) Meat, poultry, fish, dry beans, brand name, provided they are not eggs, and nuts; except that: false or misleading under section 4(h) (E) These foods will not be sauces of the Act (21 U.S.C. 453(h)(4)). (except for foods in the four food (2) [Reserved] groups in paragraph (m)(1)(ii)(A) (3) A statement that describes the through (D) of this section, that are in percentage of a vitamin or mineral in the sauces), gravies, condiments, rel- the food, including foods intended spe- ishes, pickles, olives, jams, jellies, syr- cifically for use by infants and children ups, breadings, or garnishes; and less than 2 years of age, in relation to (2) Is represented as, or is in a form commonly understood to be, a main a Reference Daily Intake (RDI) as de- dish (e.g., not a beverage or a dessert). fined in § 381.409 may be made on the Such representations may be made by label or in the labeling of a food with- statements, photographs, or vignettes. out a regulation authorizing such a (n) Nutrition labeling in accordance claim for a specific vitamin or mineral. with § 381.409 shall be provided for any (4) The requirements of this section food for which a nutrient content claim do not apply to infant formulas and is made. medical foods, as described in 21 CFR (o) Compliance with requirements for 101.13(q)(4). nutrient content claims shall be in ac- (5) [Reserved] cordance with § 381.409(h). (6) Nutrient content claims that were (p)(1) Unless otherwise specified, the part of the name of a product that was reference amount customarily con- subject to a standard of identity as of sumed set forth in § 381.412(b) through November 27, 1991, are not subject to (e) shall be used in determining wheth- the requirements of paragraph (b) of er a product meets the criteria for a this section whether or not they meet nutrient content claim. If the serving the definition of the descriptive term. size declared on the product label dif- (7) Implied nutrient content claims fers from the reference amount customarily consumed, and the amount of may be used as part of a brand name, the nutrient contained in the labeled provided that the use of the claim has serving does not meet the maximum or been authorized by FSIS. Labeling ap- minimum amount criterion in the defi- plications requesting approval of such nition for the descriptor for that nutrient, the claim shall be followed by the criteria for the claim as required by

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a claim may be submitted pursuant to ing information may also be supple- § 381.469. mented by a video, live demonstration, or other media. If a nutrition claim is [58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, 1993, as amended at 58 FR 47628, Sept. 10, made on point-of-purchase materials, 1993; 59 FR 40215, Aug. 8, 1994; 59 FR 45198, all of the format and content require- Sept. 1, 1994; 60 FR 208, Jan. 3, 1995; 69 FR ments of § 381.409 apply. However, if 58802, Oct. 1, 2004] only nutrition information—and not a nutrition claim—is supplied on point- §§ 381.414–381.443 [Reserved] of-purchase materials, the requirements of § 381.409 apply, provided, how- § 381.444 Identification of major cuts of poultry products. ever: (i) The listing of percent of Daily The major cuts of single-ingredient, Value for the nutrients (except vita- raw poultry products are: Whole chick- mins and minerals specified in en (without neck and giblets), chicken § 381.409(c)(8)) and footnote required by breast, chicken wing, chicken drum- § 381.409(d)(9) may be omitted; and stick, chicken thigh, whole turkey (ii) The point-of-purchase materials (without necks and giblets; separate are not subject to any of the format re- nutrient panels for white and dark quirements. meat permitted as an option), turkey (b) [Reserved] breast, turkey wing, turkey drumstick, (c) For the point-of-purchase mate- and turkey thigh. rials, the declaration of nutrition in- § 381.445 Nutrition labeling of single- formation may be presented in a sim- ingredient, raw poultry products plified format as specified in § 381.409(f). that are not ground or chopped (d) The nutrition label data for prod- products described in § 381.401. ucts covered in paragraphs (a)(1) and (a)(1) Nutrition information on the (a)(2) must be based on either raw or major cuts of single-ingredient, raw cooked edible portions of poultry cuts poultry products identified in § 381.444, with skin. If data are based on cooked including those that have been pre- portions, the methods used to cook the viously frozen, is required, either on products must be specified and for their label or at their point-of-pur- products covered in paragraphs (a)(1) chase, unless exempted under § 381.500. and (a)(2) must be those which do not If nutrition information is presented add nutrients from other ingredients on the label, it must be provided in ac- such as flour, breading, and salt. Addi- cordance with the provisions of tional nutritional data may be pre- § 381.409. If nutrition information is sented on an optional basis for the raw presented at the point-of-purchase, it or cooked edible portions of the skin- must be provided in accordance with less poultry meat. the provisions of this section. (e) Nutrient data that are the most (2) Nutrition information on single- current representative data base values ingredient, raw poultry products that contained in USDA’s National Nutrient are not ground or chopped poultry Data Bank or its released form, the products described in § 381.401 and are USDA National Nutrient Database for not major cuts of single-ingredient, Standard Reference, may be used for raw poultry products identified in nutrition labeling of single-ingredient, § 381.444, including those that have been raw poultry products, including those previously frozen, may be provided at that have been previously frozen. These their point-of-purchase in accordance data may be composite data that re- with the provisions of this section or flect different classes of turkey or on their label, in accordance with the other variables affecting nutrient con- provisions of § 381.409. tent. Alternatively, data that reflect (3) A retailer may provide nutrition specific classes or other variables may information at the point-of-purchase be used, except that if data are used on by various methods, such as by posting labels attached to a product which is a sign or by making the information labeled as to class of poultry or other readily available in brochures, note- variables, the data must represent the books, or leaflet form in close prox- product in the package when such data imity to the food. The nutrition label- are contained in the representative

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data base. When data are used on labels (2) The terms defined in paragraph attached to a product, the data must (b)(1) of this section may be used on represent the edible poultry tissues the label or in labeling of a meal-type present in the package. product as defined in § 381.413(l) and (f) If the nutrition information is main-dish product as defined in provided in accordance with paragraph § 381.413(m), provided that: (e) of this section, a nutrition label or (i) The product contains a food that labeling will not be subject to the meets the definition of ‘‘high’’ in para- Agency compliance review under graph (b)(1) of this section; and § 381.409(h), unless a nutrition claim is (ii) The label or labeling clearly iden- made on the basis of the representative tifies the food that is the subject of the data base values. claim (e.g., ‘‘the serving of broccoli in (g) Retailers may use data bases that this meal is high in vitamin C’’). they believe reflect the nutrient con- (c) ‘‘Good Source’’ claims. (1) The tent of single-ingredient, raw poultry terms ‘‘good source,’’ ‘‘contains,’’ or products, including those that have ‘‘provides’’ may be used on the label or been previously frozen; however, such in labeling of products, except meal- labeling shall be subject to the compli- type products as described in § 381.413(l) ance procedures of paragraph (e) of this and main-dish products as defined in section and the requirements specified § 317.313(m), provided that the product in this subpart for the mandatory nu- contains 10 to 19 percent of the RDI or trition labeling program. the DRV per reference amount custom- [58 FR 675, Jan. 6, 1993, as amended at 58 FR arily consumed. 47628, Sept. 10, 1993; 60 FR 209, Jan. 3, 1995; 75 (2) The terms defined in paragraph FR 82166, Dec. 29, 2010] (c)(1) of this section may be used on the label or in labeling of a meal-type §§ 381.446–381.453 [Reserved] product as defined in § 381.413(l) and § 381.454 Nutrient content claims for main-dish product as defined in ‘‘good source,’’ ‘‘high,’’ and ‘‘more.’’ § 381.413(m), provided that: (a) General requirements. Except as (i) The product contains a food that provided in paragraph (e) of this sec- meets the definition of ‘‘good source’’ tion, a claim about the level of a nutri- in paragraph (c)(1) of this section; and ent in a product in relation to the Ref- (ii) The label or labeling clearly iden- erence Daily Intake (RDI) or Daily Ref- tifies the food that is the subject of the erence Value (DRV), established for claim (e.g., ‘‘the serving of sweet pota- that nutrient (excluding total carbo- toes in this meal is a good source of hydrate) in § 381.409(c), may only be fiber’’). made on the label or in labeling of the (d) Fiber claims. (1) If a nutrient con- product if: tent claim is made with respect to the (1) The claim uses one of the terms level of dietary fiber, i.e., that the defined in this section in accordance product is high in fiber, a good source with the definition for that term; of fiber, or that the product contains (2) The claim is made in accordance ‘‘more’’ fiber, and the product is not with the general requirements for nu- ‘‘low’’ in total fat as defined in trient content claims in § 381.413; and § 381.462(b)(2) or, in the case of a meal- (3) The product for which the claim is type product or in a main-dish product, made is labeled in accordance with is not ‘‘low’’ in total fat as defined in § 381.409. § 381.462(b)(3), then the labeling shall (b) ‘‘High’’ claims. (1) The terms disclose the level of total fat per la- ‘‘high,’’ ‘‘rich in,’’ or ‘‘excellent source beled serving size (e.g., ‘‘contains 12 of’’ may be used on the label or in la- grams (g) of fat per serving’’); and beling of products, except meal-type (2) The disclosure shall appear in im- products as defined in § 381.413(l) and mediate proximity to such claim and main-dish products as defined in be in a type size no less than one-half § 381.413(m), provided that the product the size of the claim. contains 20 percent or more of the RDI (e) ‘‘More’’ claims. (1) A relative claim or the DRV per reference amount cus- using the terms ‘‘more’’ and ‘‘added’’ tomarily consumed. may be used on the label or in labeling

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to describe the level of protein, vita- ounces (oz) than does ‘reference prod- mins, minerals, dietary fiber, or potas- uct’ ’’), and sium in a product, except meal-type (B) Quantitative information com- products as defined in § 381.413(l) and paring the level of the nutrient in the main-dish products as defined in meal-type product or in a main-dish § 381.413(m), provided that: product per specified weight with that (i) The product contains at least 10 of the reference product that it re- percent more of the RDI or the DRV places is declared adjacent to the most for protein, vitamins, minerals, dietary prominent claim or to the nutrition in- fiber, or potassium (expressed as a per- formation (e.g., ‘‘fiber content of ‘ref- cent of the Daily Value) per reference erence product’ is 2 g per 3 oz; ‘this amount customarily consumed than an product’ contains 5 g per 3 oz’’). appropriate reference product as de- [60 FR 210, Jan. 3, 1995, as amended at 69 FR scribed in § 381.413(j)(1); and 58803, Oct. 1, 2004] (ii) As required in § 381.413(j)(2) for relative claims: § 381.455 [Reserved] (A) The identity of the reference product and the percent (or fraction) § 381.456 Nutrient content claims for that the nutrient is greater relative to ‘‘light’’ or ‘‘lite.’’ the RDI or DRV are declared in imme- (a) General requirements. A claim diate proximity to the most prominent using the terms ‘‘light’’ or ‘‘lite’’ to de- such claim (e.g., ‘‘contains 10 percent scribe a product may only be made on more of the Daily Value for fiber than the label or in labeling of the product ‘reference product’ ’’); and if: (B) Quantitative information com- (1) The claim uses one of the terms paring the level of the nutrient in the defined in this section in accordance product per labeled serving size with with the definition for that term; that of the reference product that it re- (2) The claim is made in accordance places is declared adjacent to the most with the general requirements for nu- prominent claim or to the nutrition in- trient content claims in § 381.413; and formation (e.g., ‘‘fiber content of ‘ref- (3) The product for which the claim is erence product’ is 1 g per serving; ‘this made is labeled in accordance with product’ contains 4 g per serving’’). § 381.409. (2) A relative claim using the terms (b) ‘‘Light’’ claims. The terms ‘‘light’’ ‘‘more’’ and ‘‘added’’ may be used on or ‘‘lite’’ may be used on the label or in the label or in labeling to describe the labeling of products, except meal-type level of protein, vitamins, minerals, di- products as defined in § 381.413(l) and etary fiber, or potassium in meal-type main-dish products as defined in products as defined in § 381.413(l) and § 381.413(m), without further qualifica- main-dish products as defined in tion, provided that: § 381.413(m), provided that: (1) If the product derives 50 percent (i) The product contains at least 10 or more of its calories from fat, its fat percent more of the RDI or the DRV content is reduced by 50 percent or for protein, vitamins, minerals, dietary more per reference amount custom- fiber, or potassium (expressed as a per- arily consumed compared to an appro- cent of the Daily Value) per 100 g of priate reference product as described in product than an appropriate reference § 381.413(j)(1); or product as described in § 381.413(j)(1); (2) If the product derives less than 50 and percent of its calories from fat: (ii) As required in § 381.413(j)(2) for (i) The number of calories is reduced relative claims: by at least one-third (331⁄3 percent) per (A) The identity of the reference reference amount customarily con- product and the percent (or fraction) sumed compared to an appropriate ref- that the nutrient is greater relative to erence product as described in the RDI or DRV are declared in imme- § 381.413(j)(1); or diate proximity to the most prominent (ii) Its fat content is reduced by 50 such claim (e.g., ‘‘contains 10 percent percent or more per reference amount more of the Daily Value for fiber per 3 customarily consumed compared to the

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appropriate reference product as de- erence amount customarily consumed scribed in § 381.413(j)(1); and may use the terms ‘‘light in sodium’’ (3) As required in § 381.413(j)(2) for rel- or ‘‘lite in sodium’’ if it is reduced by ative claims: 50 percent or more in sodium content (i) The identity of the reference prod- compared to the reference product, pro- uct and the percent (or fraction) that vided that ‘‘light’’ or ‘‘lite’’ is pre- the calories and the fat were reduced sented in immediate proximity with are declared in immediate proximity to ‘‘in sodium’’ and the entire term is pre- the most prominent such claim (e.g., sented in uniform type size, style, ‘‘1⁄3 fewer calories and 50 percent less color, and prominence; and fat than the market leader’’); and (ii) As required in § 381.413(j)(2) for (ii) Quantitative information com- relative claims: paring the level of calories and fat con- (A) The identity of the reference tent in the product per labeled serving product and the percent (or fraction) size with that of the reference product that the sodium was reduced are de- that it replaces is declared adjacent to clared in immediate proximity to the the most prominent claim or to the nu- most prominent such claim (e.g., ‘‘50 trition information (e.g., ‘‘lite ‘this percent less sodium than the market product’—200 calories, 4 grams (g) fat; leader’’); and regular ‘reference product’—300 cal- (B) Quantitative information com- ories, 8 g fat per serving’’); and paring the level of sodium per labeled (iii) If the labeled product contains serving size with that of the reference less than 40 calories or less than 3 g fat product it replaces is declared adjacent per reference amount customarily con- to the most prominent claim or to the sumed, the percentage reduction for nutrition information (e.g., or ‘‘lite that nutrient need not be declared. ‘this product’—170 mg sodium per serv- (4) A ‘‘light’’ claim may not be made ing; regular ‘reference product’—350 mg on a product for which the reference per serving’’). product meets the definition of ‘‘low (3) Except for meal-type products as fat’’ and ‘‘low calorie.’’ defined in § 381.413(l) and main-dish (c)(1)(i) A product for which the ref- products as defined in § 381.413(m), a erence product contains 40 calories or ‘‘light in sodium’’ claim may not be less and 3 g fat or less per reference made on a product for which the ref- amount customarily consumed may erence product meets the definition of use the terms ‘‘light’’ or ‘‘lite’’ without ‘‘low in sodium.’’ further qualification if it is reduced by (d)(1) The terms ‘‘light’’ or ‘‘lite’’ 50 percent or more in sodium content may be used on the label or in labeling compared to the reference product; and of a meal-type product as defined in (ii) As required in § 381.413(j)(2) for § 381.413(l) and main-dish product as de- relative claims: fined in § 381.413(m), provided that: (A) The identity of the reference (i) The product meets the definition product and the percent (or fraction) of: that the sodium was reduced are de- (A) ‘‘Low in calories’’ as defined in clared in immediate proximity to the § 381.460(b)(3); or most prominent such claim (e.g., ‘‘50 (B) ‘‘Low in fat’’ as defined in percent less sodium than the market § 381.462(b)(3); and leader’’); and (ii)(A) A statement appears on the (B) Quantitative information com- principal display panel that explains paring the level of sodium per labeled whether ‘‘light’’ is used to mean ‘‘low serving size with that of the reference fat,’’ ‘‘low calories,’’ or both (e.g., product it replaces is declared adjacent ‘‘Light Delight, a low fat meal’’); and to the most prominent claim or to the (B) The accompanying statement is nutrition information (e.g., ‘‘lite ‘this no less than one-half the type size of product’—500 milligrams (mg) sodium the ‘‘light’’ or ‘‘lite’’ claim. per serving; regular ‘reference prod- (2)(i) The terms ‘‘light in sodium’’ or uct’—1,000 mg sodium per serving’’). ‘‘lite in sodium’’ may be used on the (2)(i) A product for which the ref- label or in labeling of a meal-type erence product contains more than 40 product as defined in § 381.413(l) and calories or more than 3 g fat per ref- main-dish product as defined in

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§ 381.413(m), provided that the product the point where it has become part of meets the definition of ‘‘low in so- the statement of identity, such use of dium’’ as defined in § 381.461(b)(5)(i); the term ‘‘light’’ shall not be consid- and ered a nutrient content claim subject (ii) ‘‘Light’’ or ‘‘lite’’ and ‘‘in so- to the requirements in this part. dium’’ are presented in uniform type (g) The term ‘‘lightly salted’’ may be size, style, color, and prominence. used on a product to which has been (3) The terms ‘‘light’’ or ‘‘lite’’ may added 50 percent less sodium than is be used in the brand name of a product normally added to the reference prod- to describe the sodium content, pro- uct as described in § 381.413(j)(1)(i)(B) vided that: and (j)(1)(ii)(B), provided that if the (i) The product is reduced by 50 per- product is not ‘‘low in sodium’’ as de- cent or more in sodium content com- fined in § 381.461(b)(4), the statement pared to the reference product; ‘‘not a low sodium food,’’ shall appear (ii) A statement specifically stating adjacent to the nutrition information that the product is ‘‘light in sodium’’ and the information required to accom- or ‘‘lite in sodium’’ appears: pany a relative claim shall appear on (A) Contiguous to the brand name; the label or labeling as specified in and § 381.413(j)(2). (B) In uniform type size, style, color, [60 FR 210, Jan. 3, 1995, as amended at 69 FR and prominence as the product name; 58803, Oct. 1, 2004] and (iii) As required in § 381.413(j)(2) for §§ 381.457–381.459 [Reserved] relative claims: (A) The identity of the reference § 381.460 Nutrient content claims for product and the percent (or fraction) calorie content. that the sodium was reduced are de- (a) General requirements. A claim clared in immediate proximity to the about the calorie or sugar content of a most prominent such claim; and product may only be made on the label (B) Quantitative information com- or in labeling of the product if: paring the level of sodium per labeled (1) The claim uses one of the terms serving size with that of the reference defined in this section in accordance product it replaces is declared adjacent with the definition for that term; to the most prominent claim or to the (2) The claim is made in accordance nutrition information. with the general requirements for nu- (e) Except as provided in paragraphs trient content claims in § 381.413; and (b) through (d) of this section, the (3) The product for which the claim is terms ‘‘light’’ or ‘‘lite’’ may not be made is labeled in accordance with used to refer to a product that is not § 381.409. reduced in fat by 50 percent, or, if ap- (b) Calorie content claims. (1) The plicable, in calories by 1⁄3 or, when terms ‘‘calorie free,’’ ‘‘free of calories,’’ properly qualified, in sodium by 50 per- ‘‘no calories,’’ ‘‘zero calories,’’ ‘‘with- cent unless: out calories,’’ ‘‘trivial source of cal- (1) It describes some physical or ories,’’ ‘‘negligible source of calories,’’ organoleptic attribute of the product or ‘‘dietarily insignificant source of such as texture or color and the infor- calories’’ may be used on the label or mation (e.g., ‘‘light in color’’ or ‘‘light in labeling of products, provided that: in texture’’) so stated, clearly conveys (i) The product contains less than 5 the nature of the product; and calories per reference amount custom- (2) The attribute (e.g., ‘‘color’’ or arily consumed and per labeled serving ‘‘texture’’) is in the same style, color, size; and and at least one-half the type size as (ii) If the product meets this condi- the word ‘‘light’’ and in immediate tion without the benefit of special proximity thereto. processing, alteration, formulation, or (f) If a manufacturer can dem- reformulation to lower the caloric con- onstrate that the word ‘‘light’’ has tent, it is labeled to clearly refer to all been associated, through common use, products of its type and not merely to with a particular product to reflect a the particular brand to which the label physical or organoleptic attribute to attaches.

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(2) The terms ‘‘low calorie,’’ ‘‘few cal- § 381.413(l) and main-dish products as ories,’’ ‘‘contains a small amount of defined in § 318.413(m), provided that: calories,’’ ‘‘low source of calories,’’ or (i) The product contains at least 25 ‘‘low in calories’’ may be used on the percent fewer calories per reference label or in labeling of products, except amount customarily consumed than an meal-type products as defined in appropriate reference product as de- § 381.413(l) and main-dish products as scribed in § 381.413(j)(1); and defined in § 318.413(m), provided that: (ii) As required in § 381.413(j)(2) for (i)(A) The product has a reference relative claims: amount customarily consumed greater (A) The identity of the reference than 30 grams (g) or greater than 2 ta- product and the percent (or fraction) blespoons (tbsp) and does not provide that the calories differ between the two more than 40 calories per reference products are declared in immediate amount customarily consumed; or proximity to the most prominent such (B) The product has a reference claim (e.g., lower calorie ‘product’—‘‘33 amount customarily consumed of 30 g 1⁄3 percent fewer calories than our reg- or less or 2 tbsp or less and does not ular ‘product’ ’’); and provide more than 40 calories per reference amount customarily consumed (B) Quantitative information com- and per 50 g (for dehydrated products paring the level of calories in the prod- that must be reconstituted before typ- uct per labeled serving size with that of ical consumption with water or a dil- the reference product that it replaces uent containing an insignificant is declared adjacent to the most promi- amount, as defined in § 381.409(f)(1), of nent claim or to the nutrition informa- all nutrients per reference amount cus- tion (e.g., ‘‘calorie content has been re- tomarily consumed, the per-50-g cri- duced from 150 to 100 calories per serv- terion refers to the ‘‘as prepared’’ ing’’). form). (iii) Claims described in paragraph (ii) If the product meets these condi- (b)(4) of this section may not be made tions without the benefit of special on the label or in labeling of products processing, alteration, formulation, or if the reference product meets the defi- reformulation to lower the caloric con- nition for ‘‘low calorie.’’ tent, it is labeled to clearly refer to all (5) The terms defined in paragraph products of its type and not merely to (b)(4) of this section may be used on the particular brand to which the label the label or in labeling of a meal-type attaches. product as defined in § 381.413(l) and (3) The terms defined in paragraph main-dish product as defined in (b)(2) of this section may be used on § 381.413(m), provided that: the label or in labeling of a meal-type (i) The product contains at least 25 product as defined in § 381.413(l) and percent fewer calories per 100 g of prod- main-dish product as defined in uct than an appropriate reference prod- § 381.413(m), provided that: uct as described in § 381.413(j)(1); and (i) The product contains 120 calories (ii) As required in § 381.413(j)(2) for or less per 100 g of product; and relative claims: (ii) If the product meets this condi- (A) The identity of the reference tion without the benefit of special product and the percent (or fraction) processing, alteration, formulation, or that the calories differ between the two reformulation to lower the calorie con- products are declared in immediate tent, it is labeled to clearly refer to all products of its type and not merely to proximity to the most prominent such the particular brand to which it at- claim (e.g., ‘‘calorie reduced ‘product’, taches. 25% less calories per ounce (oz) (or 3 oz) (4) The terms ‘‘reduced calorie,’’ ‘‘re- than our regular ‘product’ ’’); and duced in calories,’’ ‘‘calorie reduced,’’ (B) Quantitative information com- ‘‘fewer calories,’’ ‘‘lower calorie,’’ or paring the level of calories in the prod- ‘‘lower in calories’’ may be used on the uct per specified weight with that of label or in labeling of products, except the reference product that it replaces meal-type products as defined in

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is declared adjacent to the most promi- (2) The terms ‘‘no added sugar,’’ nent claim or to the nutrition informa- ‘‘without added sugar,’’ or ‘‘no sugar tion (e.g., ‘‘calorie content has been re- added’’ may be used only if: duced from 110 calories per 3 oz to 80 (i) No amount of sugars, as defined in calories per 3 oz’’). § 381.409(c)(6)(ii), or any other ingre- (iii) Claims described in paragraph dient that contains sugars that func- (b)(5) of this section may not be made tionally substitute for added sugars is on the label or in labeling of products added during processing or packaging; if the reference product meets the defi- (ii) The product does not contain an nition for ‘‘low calorie.’’ ingredient containing added sugars such as jam, jelly, or concentrated (c) Sugar content claims. (1) Terms fruit juice; such as ‘‘sugar free,’’ ‘‘free of sugar,’’ (iii) The sugars content has not been ‘‘no sugar,’’ ‘‘zero sugar,’’ ‘‘without increased above the amount present in sugar,’’ ‘‘sugarless,’’ ‘‘trivial source of the ingredients by some means such as sugar,’’ ‘‘negligible source of sugar,’’ or the use of enzymes, except where the ‘‘dietarily insignificant source of intended functional effect of the proc- sugar’’ may reasonably be expected to ess is not to increase the sugars con- be regarded by consumers as terms tent of a product, and a functionally that represent that the product con- insignificant increase in sugars results; tains no sugars or sweeteners, e.g., (iv) The product that it resembles ‘‘sugar free,’’ or ‘‘no sugar,’’ as indi- and for which it substitutes normally cating a product which is low in cal- contains added sugars; and ories or significantly reduced in cal- (v) The product bears a statement ories. Consequently, except as provided that the product is not ‘‘low calorie’’ in paragraph (c)(2) of this section, a or ‘‘calorie reduced’’ (unless the prod- product may not be labeled with such uct meets the requirements for a ‘‘low’’ terms unless: or ‘‘reduced calorie’’ product) and that (i) The product contains less than 0.5 directs consumers’ attention to the nu- g of sugars, as defined in trition panel for further information § 381.409(c)(6)(ii), per reference amount on sugar and calorie content. customarily consumed and per labeled (3) Paragraph (c)(1) of this section serving size or, in the case of a meal- shall not apply to a factual statement type product or a main-dish product, that a product, including products in- less than 0.5 g of sugars per labeled tended specifically for infants and chil- serving size; dren less than 2 years of age, is un- (ii) The product contains no ingre- sweetened or contains no added sweet- dient that is a sugar or that is gen- eners in the case of a product that contains apparent substantial inherent erally understood by consumers to con- sugar content, e.g., juices. tain sugars unless the listing of the in- (4) The terms ‘‘reduced sugar,’’ ‘‘re- gredient in the ingredients statement duced in sugar,’’ ‘‘sugar reduced,’’ ‘‘less is followed by an asterisk that refers to sugar,’’ ‘‘lower sugar,’’ or ‘‘lower in the statement below the list of ingredi- sugar’’ may be used on the label or in ents, which states: ‘‘Adds a trivial labeling of products, except meal-type amount of sugar,’’ ‘‘adds a negligible products as defined in § 381.413(l) and amount of sugar,’’ or ‘‘adds a dietarily main-dish products as defined in insignificant amount of sugar;’’ and § 318.413(m), provided that: (iii)(A) It is labeled ‘‘low calorie’’ or (i) The product contains at least 25 ‘‘reduced calorie’’ or bears a relative percent less sugars per reference claim of special dietary usefulness la- amount customarily consumed than an beled in compliance with paragraphs appropriate reference product as de- (b)(2), (b)(3), (b)(4), or (b)(5) of this sec- scribed in § 381.413(j)(1); and tion; or (ii) As required in § 381.413(j)(2) for (B) Such term is immediately accom- relative claims: panied, each time it is used, by either (A) The identity of the reference the statement ‘‘not a reduced calorie product and the percent (or fraction) product,’’ ‘‘not a low calorie product,’’ that the sugars differ between the two or ‘‘not for weight control.’’ products are declared in immediate

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proximity to the most prominent such (3) The product for which the claim is claim (e.g., ‘‘this product contains 25 made is labeled in accordance with percent less sugar than our regular § 381.409. product’’); and (b) Sodium content claims. (1) The (B) Quantitative information com- terms ‘‘sodium free,’’ ‘‘free of sodium,’’ paring the level of the sugar in the ‘‘no sodium,’’ ‘‘zero sodium,’’ ‘‘without product per labeled serving size with sodium,’’ ‘‘trivial source of sodium,’’ that of the reference product that it re- ‘‘negligible source of sodium,’’ or places is declared adjacent to the most ‘‘dietarily insignificant source of so- prominent claim or to the nutrition in- dium’’ may be used on the label or in formation (e.g., ‘‘sugar content has labeling of products, provided that: been lowered from 8 g to 6 g per serv- (i) The product contains less than 5 ing’’). milligrams (mg) of sodium per ref- (5) The terms defined in paragraph erence amount customarily consumed (c)(4) of this section may be used on the and per labeled serving size or, in the label or in labeling of a meal-type case of a meal-type product or a main- product as defined in § 381.413(l) and dish product, less than 5 mg of sodium main-dish product as defined in per labeled serving size; § 381.413(m), provided that: (ii) The product contains no ingredient that is sodium chloride or is gen- (i) The product contains at least 25 erally understood by consumers to con- percent less sugars per 100 g of product tain sodium unless the listing of the in- than an appropriate reference product gredient in the ingredients statement as described in § 381.413(j)(1); and is followed by an asterisk that refers to (ii) As required in § 381.413(j)(2) for the statement below the list of ingredi- relative claims: ents, which states: ‘‘Adds a trivial (A) The identity of the reference amount of sodium,’’ ‘‘adds a negligible product and the percent (or fraction) amount of sodium’’ or ‘‘adds a dietarily that the sugars differ between the two insignificant amount of sodium;’’ and products are declared in immediate (iii) If the product meets these condi- proximity to the most prominent such tions without the benefit of special claim (e.g., ‘‘reduced sugar ‘product’— processing, alteration, formulation, or 25% less sugar than our regular ‘prod- reformulation to lower the sodium con- uct’ ’’); and tent, it is labeled to clearly refer to all (B) Quantitative information com- products of its type and not merely to paring the level of the nutrient in the the particular brand to which the label product per specified weight with that attaches. of the reference product that it re- (2) The terms ‘‘very low sodium’’ or places is declared adjacent to the most ‘‘very low in sodium’’ may be used on prominent claim or to the nutrition in- the label or in labeling of products, ex- formation (e.g., ‘‘sugar content has cept meal-type products as defined in been reduced from 17 g per 3 oz to 13 g § 381.413(l) and main-dish products as per 3 oz’’). defined in § 381.413(m), provided that: (i)(A) The product has a reference [60 FR 211, Jan. 3, 1995, as amended at 69 FR amount customarily consumed greater 58803, Oct. 1, 2004] than 30 grams (g) or greater than 2 tablespoons (tbsp) and contains 35 mg or § 381.461 Nutrient content claims for less sodium per reference amount cus- the sodium content. tomarily consumed; or (a) General requirements. A claim (B) The product has a reference about the level of sodium in a product amount customarily consumed of 30 g may only be made on the label or in la- or less or 2 tbsp or less and contains 35 beling of the product if: mg or less sodium per reference (1) The claim uses one of the terms amount customarily consumed and per defined in this section in accordance 50 g (for dehydrated products that must with the definition for that term; be reconstituted before typical con- (2) The claim is made in accordance sumption with water or a diluent con- with the general requirements for nu- taining an insignificant amount, as de- trient content claims in § 381.413; and fined in § 381.409(f)(1), of all nutrients

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per reference amount customarily con- products of its type and not merely to sumed, the per-50-g criterion refers to the particular brand to which the label the ‘‘as prepared’’ form); and attaches. (ii) If the product meets these condi- (5) The terms defined in paragraph tions without the benefit of special (b)(4) of this section may be used on processing, alteration, formulation, or the label or in labeling of a meal-type reformulation to lower the sodium con- product as defined in § 381.413(l) and tent, it is labeled to clearly refer to all main-dish product as defined in products of its type and not merely to § 381.413(m), provided that: the particular brand to which the label (i) The product contains 140 mg or attaches. less sodium per 100 g of product; and (3) The terms defined in paragraph (ii) If the product meets these condi- (b)(2) of this section may be used on tions without the benefit of special the label or in labeling of a meal-type processing, alteration, formulation, or product as defined in § 381.413(l) and reformulation to lower the sodium con- main-dish product as defined in tent, it is labeled to clearly refer to all § 381.413(m), provided that: products of its type and not merely to (i) The product contains 35 mg or less the particular brand to which the label of sodium per 100 g of product; and attaches. (ii) If the product meets this condi- (6) The terms ‘‘reduced sodium,’’ tion without the benefit of special ‘‘reduced in sodium,’’ ‘‘sodium reprocessing, alteration, formulation, or duced,’’ ‘‘less sodium,’’ ‘‘lower so- reformulation to lower the sodium content, it is labeled to clearly refer to all dium,’’ or ‘‘lower in sodium’’ may be products of its type and not merely to used on the label or in labeling of prod- the particular brand to which the label ucts, except meal-type products as de- attaches. fined in § 381.413(l) and main-dish prod- (4) The terms ‘‘low sodium,’’ ‘‘low in ucts as defined in § 381.413(m), provided sodium,’’ ‘‘little sodium,’’ ‘‘contains a that: small amount of sodium,’’ or ‘‘low (i) The product contains at least 25 source of sodium’’ may be used on the percent less sodium per reference label and in labeling of products, ex- amount customarily consumed than an cept meal-type products as defined in appropriate reference product as de- § 381.413(l) and main-dish products as scribed in § 381.413(j)(l); and defined in § 381.413(m), provided that: (ii) As required in § 381.413(j)(2) for (i)(A) The product has a reference relative claims: amount customarily consumed greater (A) The identity of the reference than 30 g or greater than 2 tbsp and product and the percent (or fraction) contains 140 mg or less sodium per ref- that the sodium differs between the erence amount customarily consumed; two products are declared in imme- or diate proximity to the most prominent (B) The product has a reference such claim (e.g., ‘‘reduced sodium amount customarily consumed of 30 g ‘product’, 50 percent less sodium than or less or 2 tbsp or less and contains 140 regular ‘product’ ’’); and mg or less sodium per reference (B) Quantitative information com- amount customarily consumed and per paring the level of sodium in the prod- 50 g (for dehydrated products that must uct per labeled serving size with that of be reconstituted before typical con- the reference product that it replaces sumption with water or a diluent con- is declared adjacent to the most promi- taining an insignificant amount, as de- nent claim or to the nutrition informa- fined in § 381.409(f)(1), of all nutrients tion (e.g., ‘‘sodium content has been per reference amount customarily con- lowered from 300 to 150 mg per serv- sumed, the per-50-g criterion refers to ing’’). the ‘‘as prepared’’ form); and (iii) Claims described in paragraph (ii) If the product meets these condi- (b)(6) of this section may not be made tions without the benefit of special on the label or in labeling of a product processing, alteration, formulation, or if the nutrient content of the reference reformulation to lower the sodium con- product meets the definition for ‘‘low tent, it is labeled to clearly refer to all sodium.’’

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(7) The terms defined in paragraph tion information of the product bearing (b)(6) of this section may be used on the claim. the label or in labeling of a meal-type (3) Paragraph (c)(2) of this section product as defined in § 381.413(l) and shall not apply to a factual statement main-dish product as defined in that a product intended specifically for § 381.413(m), provided that: infants and children less than 2 years (i) The product contains at least 25 of age is unsalted, provided such state- percent less sodium per 100 g of product ment refers to the taste of the product than an appropriate reference product and is not false or otherwise mis- as described in § 381.413(j)(l); and leading. (ii) As required in § 381.413(j)(2) for [60 FR 213, Jan. 3, 1995; 60 FR 5762, Jan. 30, relative claims: 1995, as amended at 69 FR 58803, Oct. 1, 2004] (A) The identity of the reference product and the percent (or fraction) § 381.462 Nutrient content claims for that the sodium differs between the fat, fatty acids, and cholesterol con- two products are declared in imme- tent. diate proximity to the most prominent (a) General requirements. A claim such claim (e.g., ‘‘reduced sodium about the level of fat, fatty acid, and ‘product’—30% less sodium per 3 oz cholesterol in a product may only be than our ‘regular product’ ’’); and made on the label or in labeling of (B) Quantitative information com- products if: paring the level of sodium in the prod- (1) The claim uses one of the terms uct per specified weight with that of defined in this section in accordance the reference product that it replaces with the definition for that term; is declared adjacent to the most promi- (2) The claim is made in accordance nent claim or to the nutrition informa- with the general requirements for nu- tion (e.g., ‘‘sodium content has been re- trient content claims in § 381.413; and duced from 220 mg per 3 oz to 150 mg (3) The product for which the claim is per 3 oz’’). made is labeled in accordance with (iii) Claims described in paragraph § 381.409. (b)(7) of this section may not be made (b) Fat content claims. (1) The terms on the label or in labeling of products ‘‘fat free,’’ ‘‘free of fat,’’ ‘‘no fat,’’ if the nutrient content of the reference ‘‘zero fat,’’ ‘‘without fat,’’ ‘‘nonfat,’’ product meets the definition for ‘‘low ‘‘trivial source of fat,’’ ‘‘negligible sodium.’’ source of fat,’’ or ‘‘dietarily insignificant source of fat’’ may be used on the (c) The term ‘‘salt’’ is not synony- label or in labeling of products, pro- mous with ‘‘sodium.’’ Salt refers to so- vided that: dium chloride. However, references to (i) The product contains less than 0.5 salt content such as ‘‘unsalted,’’ ‘‘no gram (g) of fat per reference amount salt,’’ ‘‘no salt added’’ are potentially customarily consumed and per labeled misleading. serving size or, in the case of a meal- (1) The term ‘‘salt free’’ may be used type product or a main-dish product, on the label or in labeling of products less than 0.5 g of fat per labeled serving only if the product is ‘‘sodium free’’ as size; defined in paragraph (b)(1) of this sec- (ii) The product contains no added in- tion. gredient that is a fat or is generally (2) The terms ‘‘unsalted,’’ ‘‘without understood by consumers to contain added salt,’’ and ‘‘no salt added’’ may fat unless the listing of the ingredient be used on the label or in labeling of in the ingredients statement is fol- products only if: lowed by an asterisk that refers to the (i) No salt is added during processing; statement below the list of ingredients, (ii) The product that it resembles and which states: ‘‘Adds a trivial amount of for which it substitutes is normally fat,’’ ‘‘adds a negligible amount of fat,’’ processed with salt; and or ‘‘adds a dietarily insignificant (iii) If the product is not sodium free, amount of fat’’; and the statement ‘‘not a sodium free prod- (iii) If the product meets these condi- uct’’ or ‘‘not for control of sodium in tions without the benefit of special the diet’’ appears adjacent to the nutri- processing, alteration, formulation, or

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reformulation to lower the fat content, (4) The terms ‘‘reduced fat,’’ ‘‘re- it is labeled to clearly refer to all prod- duced in fat,’’ ‘‘fat reduced,’’ ‘‘less fat,’’ ucts of its type and not merely to the ‘‘lower fat,’’ or ‘‘lower in fat’’ may be particular brand to which the label at- used on the label or in labeling of prod- taches. ucts, except meal-type products as de- (2) The terms ‘‘low fat,’’ ‘‘low in fat,’’ fined in § 381.413(l) and main-dish prod- ‘‘contains a small amount of fat,’’ ‘‘low ucts as defined in § 381.413(m), provided source of fat,’’ or ‘‘little fat’’ may be that: used on the label and in labeling of (i) The product contains at least 25 products, except meal-type products as percent less fat per reference amount defined in § 381.413(l) and main-dish customarily consumed than an appro- products as defined in § 381.413(m), propriate reference product as described in vided that: § 381.413(j)(1); and (i)(A) The product has a reference (ii) As required in § 381.413(j)(2) for amount customarily consumed greater relative claims: than 30 g or greater than 2 tablespoons (A) The identity of the reference (tbsp) and contains 3 g or less of fat per product and the percent (or fraction) reference amount customarily con- that the fat differs between the two sumed; or products are declared in immediate (B) The product has a reference proximity to the most prominent such claim (e.g., ‘‘reduced fat—50 percent amount customarily consumed of 30 g less fat than our regular ‘product’ ’’); or less or 2 tbsp or less and contains 3 and g or less of fat per reference amount (B) Quantitative information com- customarily consumed and per 50 g (for paring the level of fat in the product dehydrated products that must be re- per labeled serving size with that of the constituted before typical consumption reference product that it replaces is de- with water or a diluent containing an clared adjacent to the most prominent insignificant amount, as defined in claim or to the nutrition information § 381.409(f)(1), of all nutrients per ref- (e.g., ‘‘fat content has been reduced erence amount customarily consumed, from 8 g to 4 g per serving’’). the per-50-g criterion refers to the ‘‘as (iii) Claims described in paragraph prepared’’ form). (b)(4) of this section may not be made (ii) If the product meets these condi- on the label or in labeling of a product tions without the benefit of special if the nutrient content of the reference processing, alteration, formulation, or product meets the definition for ‘‘low reformulation to lower the fat content, fat.’’ it is labeled to clearly refer to all prod- (5) The terms defined in paragraph ucts of its type and not merely to the (b)(4) of this section may be used on particular brand to which the label at- the label or in labeling of a meal-type taches. product as defined in § 381.413(l) and (3) The terms defined in paragraph main-dish product as defined in (b)(2) of this section may be used on § 381.413(m), provided that: the label or in labeling of a meal-type (i) The product contains at least 25 product as defined in § 381.413(l) and percent less fat per 100 g of product main-dish product as defined in than an appropriate reference product § 381.413(m), provided that: as described in § 381.413(j)(1); and (i) The product contains 3 g or less of (ii) As required in § 381.413(j)(2) for total fat per 100 g of product and not relative claims: more than 30 percent of calories from (A) The identity of the reference fat; and product and the percent (or fraction) (ii) If the product meets these condi- that the fat differs between the two tions without the benefit of special products are declared in immediate processing, alteration, formulation, or proximity to the most prominent such reformulation to lower the fat content, claim (e.g., ‘‘reduced fat ‘product’, 33 it is labeled to clearly refer to all prod- percent less fat per 3 oz than our reg- ucts of its type and not merely to the ular ‘product’ ’’); and particular brand to which the label at- (B) Quantitative information com- taches. paring the level of fat in the product

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per specified weight with that of the insignificant amount of saturated fat;’’ reference product that it replaces is de- and clared adjacent to the most prominent (iii) If the product meets these condi- such claim or to the nutrition informa- tions without the benefit of special tion (e.g., ‘‘fat content has been reprocessing, alteration, formulation, or duced from 8 g per 3 oz to 5 g per 3 oz’’). reformulation to lower saturated fat (iii) Claims described in paragraph content, it is labeled to clearly refer to (b)(5) of this section may not be made all products of its type and not merely on the label or in labeling of a product to the particular brand to which the if the nutrient content of the reference label attaches. product meets the definition for ‘‘low (2) The terms ‘‘low in saturated fat,’’ fat.’’ ‘‘low saturated fat,’’ ‘‘contains a small (6) The term ‘‘llllll percent fat amount of saturated fat,’’ ‘‘low source free’’ may be used on the label or in la- of saturated fat,’’ or ‘‘a little saturated beling of products, provided that: fat’’ may be used on the label or in la- (i) The product meets the criteria for beling of products, except meal-type ‘‘low fat’’ in paragraph (b)(2) or (b)(3) of products as defined in § 381.413(l) and this section; main-dish products as defined in § 381.413(m), provided that: (ii) The percent declared and the (i) The product contains 1 g or less of words ‘‘fat free’’ are in uniform type saturated fat per reference amount cus- size; and tomarily consumed and not more than (iii) A ‘‘100 percent fat free’’ claim 15 percent of calories from saturated may be made only on products that fat; and meet the criteria for ‘‘fat free’’ in para- (ii) If the product meets these condi- graph (b)(1) of this section, that con- tions without benefit of special proc- tain less than 0.5 g of fat per 100 g, and essing, alteration, formulation, or re- that contain no added fat. formulation to lower saturated fat con- (iv) A synonym for ‘‘lll percent tent, it is labeled to clearly refer to all fat free’’ is ‘‘lll percent lean.’’ products of its type and not merely to (c) Fatty acid content claims. (1) The the particular brand to which the label terms ‘‘saturated fat free,’’ ‘‘free of attaches. saturated fat,’’ ‘‘no saturated fat,’’ (3) The terms defined in paragraph ‘‘zero saturated fat,’’ ‘‘without satu- (c)(2) of this section may be used on the rated fat,’’ ‘‘trivial source of saturated label or in labeling of a meal-type fat,’’ ‘‘negligible source of saturated product as defined in § 381.413(l) and fat,’’ or ‘‘dietarily insignificant source main-dish product as defined in of saturated fat’’ may be used on the § 381.413(m), provided that: label or in labeling of products, pro- (i) The product contains 1 g or less of vided that: saturated fat per 100 g and less than 10 (i) The product contains less than 0.5 percent calories from saturated fat; g of saturated fat and less than 0.5 g and trans fatty acids per reference amount (ii) If the product meets these condi- customarily consumed and per labeled tions without the benefit of special serving size or, in the case of a meal- processing, alteration, formulation, or type product or a main-dish product, reformulation to lower saturated fat less than 0.5 g of saturated fat and less content, it is labeled to clearly refer to than 0.5 g trans fatty acids per labeled all products of its type and not merely serving size; to the particular brand to which the (ii) The product contains no ingre- label attaches. dient that is generally understood by (4) The terms ‘‘reduced saturated consumers to contain saturated fat un- fat,’’ ‘‘reduced in saturated fat,’’ less the listing of the ingredient in the ‘‘saturated fat reduced,’’ ‘‘less satu- ingredients statement is followed by an rated fat,’’ ‘‘lower saturated fat,’’ or asterisk that refers to the statement ‘‘lower in saturated fat’’ may be used below the list of ingredients, which on the label or in labeling of products, states: ‘‘Adds a trivial amount of satu- except meal-type products as defined in rated fat,’’ ‘‘adds a negligible amount § 381.413(l) and main-dish products as of saturated fat,’’ or ‘‘adds a dietarily defined in § 381.413(m), provided that:

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(i) The product contains at least 25 has been reduced from 2.5 g per 3 oz to percent less saturated fat per reference 1.5 g per 3 oz’’). amount customarily consumed than an (iii) Claims described in paragraph appropriate reference product as de- (c)(5) of this section may not be made scribed in § 381.413(j)(1); and on the label or in labeling of a product (ii) As required in § 381.413(j)(2) for if the nutrient content of the reference relative claims: product meets the definition for ‘‘low (A) The identity of the reference saturated fat.’’ product and the percent (or fraction) (d) Cholesterol content claims. (1) The that the saturated fat differs between terms ‘‘cholesterol free,’’ ‘‘free of cho- the two products are declared in imme- lesterol,’’ ‘‘zero cholesterol,’’ ‘‘without diate proximity to the most prominent cholesterol,’’ ‘‘no cholesterol,’’ ‘‘trivial such claim (e.g., ‘‘reduced saturated fat source of cholesterol,’’ ‘‘negligible ‘product’, contains 50 percent less satu- source of cholesterol,’’ or ‘‘dietarily in- rated fat than the national average for significant source of cholesterol’’ may ‘product’ ’’); and be used on the label or in labeling of (B) Quantitative information com- products, provided that: paring the level of saturated fat in the (i) The product contains less than 2 product per labeled serving size with milligrams (mg) of cholesterol per ref- that of the reference product that it re- erence amount customarily consumed and per labeled serving size or, in the places is declared adjacent to the most case of a meal-type product as defined prominent claim or to the nutrition in- in § 381.413(l) and main-dish product as formation (e.g., ‘‘saturated fat reduced defined in § 381.413(m), less than 2 mg of from 3 g to 1.5 g per serving’’). cholesterol per labeled serving size; (iii) Claims described in paragraph (ii) The product contains no ingre- (c)(4) of this section may not be made dient that is generally understood by on the label or in labeling of a product consumers to contain cholesterol, un- if the nutrient content of the reference less the listing of the ingredient in the product meets the definition for ‘‘low ingredients statement is followed by an saturated fat.’’ asterisk that refers to the statement (5) The terms defined in paragraph below the list of ingredients, which (c)(4) of this section may be used on the states: ‘‘Adds a trivial amount of cho- label or in labeling of a meal-type lesterol,’’ ‘‘adds a negligible amount of product as defined in § 381.413(l) and cholesterol,’’ or ‘‘adds a dietarily insig- main-dish product as defined in nificant amount of cholesterol’’; § 381.413(m), provided that: (iii) The product contains 2 g or less (i) The product contains at least 25 of saturated fat per reference amount percent less saturated fat per 100 g of customarily consumed or, in the case product than an appropriate reference of a meal-type product as defined in product as described in § 381.413(j)(1); § 381.413(l) and main-dish product as de- and fined in § 381.413(m), 2 g or less of satu- (ii) As required in § 381.413(j)(2) for rated fat per labeled serving size; and relative claims: (iv) If the product meets these condi- (A) The identity of the reference tions without the benefit of special product and the percent (or fraction) processing, alteration, formulation, or that the saturated fat differs between reformulation to lower cholesterol con- the two products are declared in imme- tent, it is labeled to clearly refer to all diate proximity to the most prominent products of its type and not merely to such claim (e.g., ‘‘reduced saturated fat the particular brand to which it at- ‘product’, 50 percent less saturated fat taches; or than our regular ‘product’ ’’); and (v) If the product meets these condi- (B) Quantitative information com- tions only as a result of special proc- paring the level of saturated fat in the essing, alteration, formulation, or re- product per specified weight with that formulation, the amount of cholesterol of the reference product that it re- is reduced by 25 percent or more from places is declared adjacent to the most the reference product it replaces as de- prominent claim or to the nutrition in- scribed in § 381.413(j)(1) and for which it formation (e.g., ‘‘saturated fat content substitutes as described in § 381.413(d)

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that has a significant (e.g., 5 percent or reformulation to lower cholesterol con- more of a national or regional market) tent, it is labeled to clearly refer to all market share. As required in products of its type and not merely to § 381.413(j)(2) for relative claims: the particular brand to which the label (A) The identity of the reference attaches; or product and the percent (or fraction) (iii) If the product contains 20 mg or that the cholesterol was reduced are less of cholesterol only as a result of declared in immediate proximity to the special processing, alteration, formula- most prominent such claim (e.g., ‘‘cho- tion, or reformulation, the amount of lesterol free ‘product’, contains 100 per- cholesterol is reduced by 25 percent or cent less cholesterol than ‘reference more from the reference product it re- product’ ’’); and places as described in § 381.413(j)(1) and (B) Quantitative information com- for which it substitutes as described in paring the level of cholesterol in the § 381.413(d) that has a significant (e.g., 5 product per labeled serving size with percent or more of a national or re- that of the reference product that it regional market) market share. As replaces is declared adjacent to the most quired in § 381.413(j)(2) for relative prominent claim or to the nutrition in- claims: formation (e.g., ‘‘contains no choles- (A) The identity of the reference terol compared with 30 mg in one serv- product and the percent (or fraction) ing of ‘reference product’ ’’). that the cholesterol has been reduced (2) The terms ‘‘low in cholesterol,’’ are declared in immediate proximity to ‘‘low cholesterol,’’ ‘‘contains a small the most prominent such claim (e.g., amount of cholesterol,’’ ‘‘low source of ‘‘low cholesterol ‘product’, contains 85 cholesterol,’’ or ‘‘little cholesterol’’ percent less cholesterol than our reg- may be used on the label or in labeling ular ‘product’’’); and of products, except meal-type products (B) Quantitative information com- as defined in § 381.413(l) and main-dish paring the level of cholesterol in the products as defined in § 381.413(m), pro- product per labeled serving size with vided that: that of the reference product that it re- (i)(A) If the product has a reference places is declared adjacent to the most amount customarily consumed greater prominent claim or to the nutrition in- than 30 g or greater than 2 tbsp: formation (e.g., ‘‘cholesterol lowered (1) The product contains 20 mg or less from 30 mg to 5 mg per serving’’). of cholesterol per reference amount (3) The terms defined in paragraph customarily consumed; and (d)(2) of this section may be used on (2) The product contains 2 g or less of the label or in labeling of a meal-type saturated fat per reference amount cus- product as defined in § 381.413(l) and tomarily consumed; or main-dish product as defined in (B) If the product has a reference § 381.413(m), provided that: amount customarily consumed of 30 g (i) The product contains 20 mg or less or less or 2 tbsp or less: of cholesterol per 100 g of product; (1) The product contains 20 mg or less (ii) The product contains 2 g or less of cholesterol per reference amount of saturated fat per 100 g of product; customarily consumed and per 50 g (for and dehydrated products that must be re- (iii) If the product meets these condi- constituted before typical consumption tions without the benefit of special with water or a diluent containing an processing, alteration, formulation, or insignificant amount, as defined in reformulation to lower cholesterol con- § 381.409(f)(1), of all nutrients per ref- tent, it is labeled to clearly refer to all erence amount customarily consumed, products of its type and not merely to the per-50-g criterion refers to the ‘‘as the particular brand to which the label prepared’’ form); and attaches. (2) The product contains 2 g or less of (4) The terms ‘‘reduced cholesterol,’’ saturated fat per reference amount cus- ‘‘reduced in cholesterol,’’ ‘‘cholesterol tomarily consumed. reduced,’’ ‘‘less cholesterol,’’ ‘‘lower (ii) If the product meets these condi- cholesterol,’’ or ‘‘lower in cholesterol’’ tions without the benefit of special may be used on the label or in labeling processing, alteration, formulation, or of products or products that substitute

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for those products as specified in (iii) As required in § 381.413(j)(2) for § 381.413(d), excluding meal-type prod- relative claims: ucts as defined in § 381.413(l) and main- (A) The identity of the reference dish products as defined in § 381.413(m), product and the percent (or fraction) provided that: that the cholesterol has been reduced (i) The product has been specifically are declared in immediate proximity to formulated, altered, or processed to re- the most prominent such claim (e.g., duce its cholesterol by 25 percent or ‘‘25% less cholesterol than ‘reference more from the reference product it re- product’ ’’); and places as described in § 381.413(j)(1) and (B) Quantitative information com- for which it substitutes as described in paring the level of cholesterol in the § 381.413(d) that has a significant (e.g., 5 product per specified weight with that percent or more of a national or re- of the reference product that it regional market) market share; places is declared adjacent to the most (ii) The product contains 2 g or less prominent claim or to the nutrition in- of saturated fat per reference amount formation (e.g., ‘‘cholesterol content customarily consumed; and has been reduced from 35 mg per 3 oz to (iii) As required in § 381.413(j)(2) for 25 mg per 3 oz). relative claims: (iv) Claims described in paragraph (A) The identity of the reference (d)(5) of this section may not be made product and the percent (or fraction) on the label or in labeling of a product that the cholesterol has been reduced if the nutrient content of the reference are declared in immediate proximity to product meets the definition for ‘‘low the most prominent such claim (e.g., cholesterol.’’ ‘‘25 percent less cholesterol than ‘ref- (e) ‘‘Lean’’ and ‘‘Extra Lean’’ claims. erence product’ ’’); and (1) The term ‘‘lean’’ may be used on the (B) Quantitative information com- label or in labeling of a product, pro- paring the level of cholesterol in the vided that the product contains less product per labeled serving size with than 10 g of fat, 4.5 g or less of satu- that of the reference product that it re- rated fat, and less than 95 mg of choles- places is declared adjacent to the most terol per 100 g of product and per ref- prominent claim or to the nutrition in- erence amount customarily consumed formation (e.g., ‘‘cholesterol lowered for individual foods, and per 100 g of from 55 mg to 30 mg per serving’’). product and per labeled serving size for (iv) Claims described in paragraph meal-type products as defined in (d)(4) of this section may not be made § 381.413(l) and main-dish products as on the label or in labeling of a product defined in § 381.413(m). if the nutrient content of the reference (2) The term ‘‘extra lean’’ may be product meets the definition for ‘‘low used on the label or in labeling of a cholesterol.’’ product, provided that the product con- (5) The terms defined in paragraph tains less than 5 g of fat, less than 2 g (d)(4) of this section may be used on of saturated fat, and less than 95 mg of the label or in labeling of a meal-type cholesterol per 100 g of product and per product as defined in § 381.413(l) and reference amount customarily con- main-dish product as defined in sumed for individual foods, and per 100 § 381.413(m), provided that: g of product and per labeled serving (i) The product has been specifically size for meal-type products as defined formulated, altered, or processed to rein § 381.413(l) and main-dish products as duce its cholesterol by 25 percent or defined in § 381.413(m). more from the reference product it re- (f) A statement of the lean percent- places as described in § 381.413(j)(1) and age may be used on the label or in la- for which it substitutes as described in beling of ground or chopped poultry § 381.413(d) that has a significant (e.g., 5 products described in § 381.401 when the percent or more of a national or re- product does not meet the criteria for gional market) market share; ‘‘low fat,’’ defined in § 381.462(b)(2), pro- (ii) The product contains 2 g or less vided that a statement of the fat per- of saturated fat per 100 g of product; centage is contiguous to and in let- and tering of the same color, size, type, and

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on the same color background, as the (i) A main-dish product, as defined in statement of the lean percentage. § 381.413(m), and meal-type product, as defined in § 381.413(l), and including [60 FR 214, Jan. 3, 1995, as amended at 69 FR meal-type products that weigh more 58803, Oct. 1, 2004; 75 FR 82167, Dec. 29, 2010] than 12 oz per serving (container), shall § 381.463 Nutrient content claims for not contain more than 600 mg of so- ‘‘healthy.’’ dium per labeled serving size;1 and (ii) The requirements of this para- (a) The term ‘‘healthy,’’ or any other graph (b)(3) do not apply to single-in- derivative of the term ‘‘health,’’ may gredient, raw products. be used on the labeling of any poultry (4) The product shall contain 10 per- product, provided that the product is cent or more of the Reference Daily In- labeled in accordance with § 381.409 and take or Daily Reference Value as de- § 381.413. fined in § 381.409 for vitamin A, vitamin (b)(1) The product shall meet the re- C, iron, calcium, protein, or fiber per quirements for ‘‘low fat’’ and ‘‘low reference amount customarily con- saturated fat,’’ as defined in § 381.462, sumed prior to any nutrient addition, except that single-ingredient, raw except that: products may meet the total fat and (i) A main-dish product, as defined in saturated fat criteria for ‘‘extra lean’’ § 381.413(m), and including meal-type in § 381.462. products that weigh less than 10 oz per (2) The product shall not contain serving (container), shall meet the more than 60 milligrams (mg) of cho- level for two of the nutrients per la- lesterol per reference amount custom- beled serving size; and arily consumed, per labeled serving (ii) A meal-type product, as defined size, and, only for foods with reference in § 381.413(l), shall meet the level for amounts customarily consumed of 30 three of the nutrients per labeled serv- grams (g) or less or 2 tablespoons (tbsp) ing size. or less, per 50 g, and, for dehydrated products that must be reconstituted [59 FR 24228, May 10, 1994, as amended at 60 with water or a diluent containing an FR 217, Jan. 3, 1995; 63 FR 7281, Feb. 13, 1998; insignificant amount, as defined in 64 FR 72492, Dec. 28, 1999; 68 FR 463, Jan. 6, § 381.409(f)(1), of all nutrients, the per- 2003; 69 FR 58803, Oct. 1, 2004; 71 FR 1686, Jan. 11, 2006] 50-g criterion refers to the prepared form, except that: §§ 381.464–381.468 [Reserved] (i) A main-dish product, as defined in § 381.413(m), and meal-type product, as § 381.469 Labeling applications for nu- defined in § 381.413(l), and including trient content claims. meal-type products that weigh more (a) This section pertains to labeling than 12 ounces (oz) per serving (con- applications for claims, express or im- tainer), shall not contain more than 90 plied, that characterize the level of any mg of cholesterol per labeled serving nutrient required to be on the label or size; and in labeling of product by this subpart. (ii) Single-ingredient, raw products (b) Labeling applications included in may meet the cholesterol criterion for this section are: ‘‘extra lean’’ in § 381.462. (3) The product shall not contain 1 This regulation previously provided that, more than 480 mg of sodium per ref- after January 1, 2006, individual poultry erence amount customarily consumed, products bearing the claim ‘‘healthy’’ (or per labeled serving size, and, only for any derivative of the term ‘‘health’’) must foods with reference amounts custom- contain no more than 360 mg of sodium and arily consumed of 30 g or less or 2 tbsp that meal-type products bearing the claim or less, per 50 g, and, for dehydrated ‘‘healthy’’ (or any other derivative of the products that must be reconstituted term ‘‘health’’) must contain no more than with water or a diluent containing an 600 mg of sodium. Implementation of these sodium level requirements for products bear- insignificant amount, as defined in ing the claim ‘‘healthy’’ (or any derivative of § 381.409(f)(1), of all nutrients, the per- the term ‘‘health’’) has been deferred indefi- 50-g criterion refers to the prepared nitely due to technological barriers and conform, except that: sumer preferences.

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(1) Labeling applications for a new compliance with the requirements for (heretofore unauthorized) nutrient con- institutional review set forth in part 56 tent claim, of chapter 1, title 21, or was not subject (2) Labeling applications for a syn- to such requirements in accordance onymous term (i.e., one that is con- with § 56.194 or § 56.105, and that it was sistent with a term defined by regula- conducted in compliance with the re- tion) for characterizing the level of a quirements for informed consents set nutrient, and forth in part 50 of chapter 1, title 21. (3) Labeling applications for the use (g) The availability for public disclo- of an implied claim in a brand name. sure of labeling applications, along (c) Labeling applications and sup- with supporting documentation, sub- porting documentation to be filed mitted to the Agency under this sec- under this section shall be submitted tion will be governed by the rules spec- in quadruplicate, except that the sup- ified in subchapter D, title 9. porting documentation may be sub- (h) The data specified under this sec- mitted on a computer disc copy. If any tion to accompany a labeling applica- part of the material submitted is in a tion shall be submitted on separate foreign language, it shall be accom- sheets, suitably identified. If such data panied by an accurate and complete has already been submitted with an English translation. The labeling appli- earlier labeling application from the cation shall state the applicant’s post applicant, the present labeling applica- office address. tion must provide the data. (d) Pertinent information will be (i) The labeling application must be considered as part of an application on signed by the applicant or by his or her the basis of specific reference to such attorney or agent, or (if a corporation) information submitted to and retained by an authorized official. in the files of the Food Safety and In- (j) The labeling application shall inspection Service. However, any ref- clude a statement signed by the person erence to unpublished information fur- responsible for the labeling applica- nished by a person other than the ap- tion, that to the best of his or her plicant will not be considered unless knowledge, it is a representative and use of such information is authorized balanced submission that includes un- (with the understanding that such in- favorable information, as well as favor- formation may in whole or part be sub- able information, known to him or her ject to release to the public) in a writ- pertinent to the evaluation of the la- ten statement signed by the person beling application. who submitted it. Any reference to (k)(1) Labeling applications for a new published information should be ac- nutrient content claim shall be accom- companied by reprints or photostatic panied by the following data which copies of such references. shall be submitted in the following (e) If nonclinical laboratory studies form to the Director, Food Labeling accompany a labeling application, the Division, Regulatory Programs, Food applicant shall include, with respect to Safety and Inspection Service, Wash- each nonclinical study included with ington, DC 20250: the application, either a statement llllllllllllllllllllllll that the study has been, or will be, (Date) conducted in compliance with the good The undersigned, llllll submits this laboratory practice regulations as set labeling application pursuant to 9 CFR forth in part 58 of chapter 1, title 21, or, 381.469 with respect to (statement of the if any such study was not conducted in claim and its proposed use). compliance with such regulations, a Attached hereto, in quadruplicate, or on a brief statement of the reason for the computer disc copy, and constituting a part noncompliance. of this labeling application, are the fol- (f) If clinical investigations accom- lowing: pany a labeling application, the appli- (i) A statement identifying the nutrient content claim and the nutrient that the cant shall include, with respect to each term is intended to characterize with respect clinical investigation included with the to the level of such nutrient. The statement application, either a statement that shall address why the use of the term as pro- the investigation was conducted in posed will not be misleading. The statement

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shall provide examples of the nutrient con- cy review and that the applicant shall tent claim as it will be used on labels or la- subsequently be notified of the Agen- beling, as well as the types of products on cy’s decision to consider for further re- which the claim will be used. The statement shall also specify the level at which the nu- view or deny the labeling application. trient must be present or what other condi- (3) Upon review of the labeling appli- tions concerning the product must be met cation and supporting documentation, for the appropriate use of the term in labels the Agency shall notify the applicant, or labeling, as well as any factors that would in writing, that the labeling applica- make the use of the term inappropriate. tion is either being considered for fur- (ii) A detailed explanation supported by ther review or that it has been sum- any necessary data of why use of the food marily denied by the Administrator. component characterized by the claim is of importance in human nutrition by virtue of (4) If the labeling application is sum- its presence or absence at the levels that marily denied by the Administrator, such claim would describe. This explanation the written notification shall state the shall also state what nutritional benefit to reasons therefor, including why the the public will derive from use of the claim Agency has determined that the pro- as proposed and why such benefit is not posed nutrient content claim is false or available through the use of existing terms misleading. The notification letter defined by regulation. If the claim is intended for a specific group within the popu- shall inform the applicant that the ap- lation, the analysis shall specifically address plicant may submit a written state- nutritional needs of such group, and sci- ment by way of answer to the notifica- entific data sufficient for such purpose, and tion, and that the applicant shall have data and information to the extent necessary the right to request a hearing with re- to demonstrate that consumers can be ex- spect to the merits or validity of the pected to understand the meaning of the Administrator’s decision to deny the term under the proposed conditions of use. (iii) Analytical data that demonstrates the use of the proposed nutrient content amount of the nutrient that is present in the claim. products for which the claim is intended. (i) If the applicant fails to accept the The assays should be performed on rep- determination of the Administrator resentative samples in accordance with and files an answer and requests a 381.409(h). If no USDA or AOAC methods are hearing, and the Administrator, after available, the applicant shall submit the review of the answer, determines the assay method used, and data establishing the validity of the method for assaying the nu- initial determination to be correct, the trient in the particular food. The validation Administrator shall file with the Hear- data shall include a statistical analysis of ing Clerk of the Department the notifi- the analytical and product variability. cation, answer, and the request for a (iv) A detailed analysis of the potential ef- hearing, which shall constitute the fect of the use of the proposed claim on food complaint and answer in the pro- consumption, and any corresponding changes ceeding, which shall thereafter be con- in nutrient intake. The analysis shall specifically address the intake of nutrients that ducted in accordance with the Depart- have beneficial and negative consequences in ment’s Uniform Rules of Practice. the total diet. If the claim is intended for a (ii) The hearing shall be conducted specific group within the population, the before an administrative law judge above analysis shall specifically address the with the opportunity for appeal to the dietary practices of such group, and shall in- Department’s Judicial Officer, who clude data sufficient to demonstrate that the shall make the final determination for dietary analysis is representative of such the Secretary. Any such determination group. by the Secretary shall be conclusive Yours very truly, unless, within 30 days after receipt of Applicant lllllllllllllll notice of such final determination, the By lllllllllllllllllll applicant appeals to the United States (Indicate authority) Court of Appeals for the circuit in (2) Upon receipt of the labeling appli- which the applicant has its principal cation and supporting documentation, place of business or to the United the applicant shall be notified, in writ- States Court of Appeals for the District ing, of the date on which the labeling of Columbia Circuit. application was received. Such notice (5) If the labeling application is not shall inform the applicant that the la- summarily denied by the Adminis- beling application is undergoing Agen- trator, the Administrator shall publish

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in the FEDERAL REGISTER a proposed States Court of Appeals for the circuit rule to amend the regulations to au- in which the applicant has its principal thorize the use of the nutrient content place of business or to the United claim. The proposal shall also summa- States Court of Appeals for the District rize the labeling application, including of Columbia Circuit. where the supporting documentation (ii) If the claim is approved, the can be reviewed. The Administrator’s Agency shall notify the applicant, in proposed rule shall seek comment from writing, and shall also publish in the consumers, the industry, consumer and FEDERAL REGISTER a final rule amend- industry groups, and other interested ing the regulations to authorize the persons on the labeling application and use of the claim. the use of the proposed nutrient con- (l)(1) Labeling applications for a syn- tent claim. After public comment has onymous term shall be accompanied by been received and reviewed by the the following data which shall be sub- Agency, the Administrator shall make mitted in the following form to the Di- a determination on whether the pro- rector, Food Labeling Division, Regu- posed nutrient content claim shall be latory Programs, Food Safety and In- approved for use on the labeling of spection Service, Washington, DC 20250: poultry products. llllllllllllllllllllllll (i) If the claim is denied by the Ad- (Date) ministrator, the Agency shall notify The undersigned, llllll submits this the applicant, in writing, of the basis labeling application pursuant to 9 CFR for the denial, including the reason 381.469 with respect to (statement of the syn- why the claim on the labeling was de- onymous term and its proposed use in a nu- termined by the Agency to be false or trient content claim that is consistent with misleading. The notification letter an existing term that has been defined under subpart Y of part 381). shall also inform the applicant that the Attached hereto, in quadruplicate, or on a applicant may submit a written state- computer disc copy, and constituting a part ment by way of answer to the notifica- of this labeling application, are the fol- tion, and that the applicant shall have lowing: the right to request a hearing with re- (i) A statement identifying the synony- spect to the merits or validity of the mous term, the existing term defined by a Administrator’s decision to deny the regulation with which the synonymous term is claimed to be consistent, and the nutrient use of the proposed nutrient content that the term is intended to characterize the claim. level of. The statement shall address why the (A) If the applicant fails to accept use of the synonymous term as proposed will the determination of the Adminis- not be misleading. The statement shall pro- trator and files an answer and requests vide examples of the nutrient content claim a hearing, and the Administrator, after as it will be used on labels or labeling, as review of the answer, determines the well as the types of products on which the claim will be used. The statement shall also initial determination to be correct, the specify whether any limitations not applica- Administrator shall file with the Hear- ble to the use of the defined term are in- ing Clerk of the Department the notifi- tended to apply to the use of the synony- cation, answer, and the request for a mous term. hearing, which shall constitute the (ii) A detailed explanation supported by complaint and answer in the pro- any necessary data of why use of the proceeding, which shall thereafter be con- posed term is requested, including whether the existing defined term is inadequate for ducted in accordance with the Depart- the purpose of effectively characterizing the ment’s Uniform Rules of Practice. level of a nutrient. This explanation shall (B) The hearing shall be conducted also state what nutritional benefit to the before an administrative law judge public will derive from use of the claim as with the opportunity for appeal to the proposed, and why such benefit is not avail- Department’s Judicial Officer, who able through use of existing terms defined by shall make the final determination for regulation. If the claim is intended for a spe- the Secretary. Any such determination cific group within the population, the analysis shall specifically address nutritional by the Secretary shall be conclusive needs of such group, scientific data sufficient unless, within 30 days after receipt of for such purpose, and data and information the notice of such final determination, to the extent necessary to demonstrate that the applicant appeals to the United consumers can be expected to understand the

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meaning of the term under the proposed con- by the Secretary shall be conclusive ditions of use. unless, within 30 days after receipt of Yours very truly, notice of such final determination, the Applicant lllllllllllllll applicant appeals to the United States By lllllllllllllllllll Court of Appeals for the circuit in (Indicate authority) which the applicant has its principal (2) Upon receipt of the labeling appli- place of business or to the United cation and supporting documentation, States Court of Appeals for the District the applicant shall be notified, in writ- of Columbia Circuit. ing, of the date on which the labeling (5) If the claim is approved, the Agen- application was received. Such notice cy shall notify the applicant, in writ- shall inform the applicant that the la- ing, and shall publish in the FEDERAL beling application is undergoing Agen- REGISTER a notice informing the public cy review and that the applicant shall that the synonymous term has been ap- subsequently be notified of the Agen- proved for use. cy’s decision to consider for further re- (m)(1) Labeling applications for the view or deny the labeling application. use of an implied nutrient content (3) Upon review of the labeling appli- claim in a brand name shall be accom- cation and supporting documentation, panied by the following data which the Agency shall notify the applicant, shall be submitted in the following in writing, that the labeling applica- form to the Director, Food Labeling tion is either being considered for fur- Division, Regulatory Programs, Food ther review or that it has been sum- Safety and Inspection Service, Wash- marily denied by the Administrator. ington, DC 20250: (4) If the labeling application is summarily denied by the Administrator, llllllllllllllllllllllll (Date) the written notification shall state the reasons therefor, including why the The undersigned, llllll submits this Agency has determined that the pro- labeling application pursuant to 9 CFR 381.469 with respect to (statement of the imposed synonymous term is false or mis- plied nutrient content claim and its proposed leading. The notification letter shall use in a brand name). inform the applicant that the applicant Attached hereto, in quadruplicate, or on a may submit a written statement by computer disc copy, and constituting a part way of answer to the notification, and of this labeling application, are the fol- that the applicant shall have the right lowing: to request a hearing with respect to (i) A statement identifying the implied nu- the merits or validity of the Adminis- trient content claim, the nutrient the claim trator’s decision to deny the use of the is intended to characterize, the corresponding term for characterizing the level proposed synonymous term. of such nutrient as defined by a regulation, (i) If the applicant fails to accept the and the brand name of which the implied determination of the Administrator claim is intended to be a part. The statement and files an answer and requests a shall address why the use of the brand-name hearing, and the Administrator, after as proposed will not be misleading. The review of the answer, determines the statement shall provide examples of the initial determination to be correct, the types of products on which the brand name Administrator shall file with the Hear- will appear. It shall also include data showing that the actual level of the nutrient in ing Clerk of the Department the notifi- the food would qualify the label of the prod- cation, answer, and the request for a uct to bear the corresponding term defined hearing, which shall constitute the by regulation. Assay methods used to deter- complaint and answer in the pro- mine the level of a nutrient shall meet the ceeding, which shall thereafter be con- requirements stated under labeling applica- ducted in accordance with the Depart- tion format in paragraph (k)(1)(iii) of this ment’s Uniform Rules of Practice. section. (ii) The hearing shall be conducted (ii) A detailed explanation supported by before an administrative law judge any necessary data of why use of the proposed brand name is requested. This expla- with the opportunity for appeal to the nation shall also state what nutritional ben- Department’s Judicial Officer, who efit to the public will derive from use of the shall make the final determination for brand name as proposed. If the branded prod- the Secretary. Any such determination uct is intended for a specific group within

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the population, the analysis shall specifi- shall make the final determination for cally address nutritional needs of such group the Secretary. Any such determination and scientific data sufficient for such pur- by the Secretary shall be conclusive pose. unless, within 30 days after receipt of Yours very truly, notice of such final determination, the Applicant lllllllllllllll applicant appeals to the United States By lllllllllllllllllll Court of Appeals for the circuit in (2) Upon receipt of the labeling appli- which the applicant has its principal cation and supporting documentation, place of business or to the United the applicant shall be notified, in writ- States Court of Appeals for the District ing, of the date on which the labeling of Columbia Circuit. application was received. Such notice (5) If the labeling application is not shall inform the applicant that the la- summarily denied by the Adminis- beling application is undergoing Agen- trator, the Administrator shall publish cy review and that the applicant shall a notice of the labeling application in subsequently be notified of the Agen- the FEDERAL REGISTER seeking a com- cy’s decision to consider for further re- ment on the use of the implied nutrient view or deny the labeling application. content claim. The notice shall also (3) Upon review of the labeling appli- summarize the labeling application, in- cation and supporting documentation, cluding where the supporting docu- the Agency shall notify the applicant, mentation can be reviewed. The Ad- in writing, that the labeling applica- ministrator’s notice shall seek com- tion is either being considered for fur- ment from consumers, the industry, ther review or that it has been sum- consumer and industry groups, and marily denied by the Administrator. other interested persons on the label- (4) If the labeling application is sum- ing application and the use of the im- marily denied by the Administrator, plied nutrient content claim. After the written notification shall state the public comment has been received and reasons therefor, including why the reviewed by the Agency, the Adminis- Agency has determined that the pro- trator shall make a determination on posed implied nutrient content claim is whether the implied nutrient content false or misleading. The notification claim shall be approved for use on the letter shall inform the applicant that labeling of poultry products. the applicant may submit a written (i) If the claim is denied by the Ad- statement by way of answer to the no- ministrator, the Agency shall notify tification, and that the applicant shall the applicant, in writing, of the basis have the right to request a hearing for the denial, including the reason with respect to the merits or validity why the claim on the labeling was de- of the Administrator’s decision to deny termined by the Agency to be false or the use of the proposed implied nutri- misleading. The notification letter ent content claim. shall also inform the applicant that the (i) If the applicant fails to accept the applicant may submit a written state- determination of the Administrator ment by way of answer to the notifica- and files an answer and requests a tion, and that the applicant shall have hearing, and the Administrator, after the right to request a hearing with re- review of the answer, determines the spect to the merits or validity of the initial determination to be correct, the Administrator’s decision to deny the Administrator shall file with the Hear- use of the proposed implied nutrient ing Clerk of the Department the notifi- content claim. cation, answer, and the request for a (A) If the applicant fails to accept hearing, which shall constitute the the determination of the Adminis- complaint and answer in the pro- trator and files an answer and requests ceeding, which shall thereafter be con- a hearing, and the Administrator, after ducted in accordance with the Depart- review of the answer, determines the ment’s Uniform Rules of Practice. initial determination to be correct, the (ii) The hearing shall be conducted Administrator shall file with the Hear- before an administrative law judge ing Clerk of the Department the notifi- with the opportunity for appeal to the cation, answer, and the request for a Department’s Judicial Officer, who hearing, which shall constitute the

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complaint and answer in the pro- (2) A special dietary product may ceeding, which shall thereafter be con- contain a nonnutritive sweetener or ducted in accordance with the Depart- other ingredient only if the ingredient ment’s Uniform Rules of Practice. is safe for use in the product under the (B) The hearing shall be conducted applicable law and regulations of this before an administrative law judge chapter. Any product that achieves its with the opportunity for appeal to the special dietary usefulness in reducing Department’s Judicial Officer, who or maintaining body weight through shall make the final determination for the use of a nonnutritive sweetener the Secretary. Any such determination shall bear on its label the statement by the Secretary shall be conclusive required by paragraph (b)(1) of this sec- unless, within 30 days after receipt of tion, but need not state the percentage the notice of such final determination, by weight of the nonnutritive sweet- the applicant appeals to the United ener. If a nutritive sweetener(s) as well States Court of Appeals for the circuit as nonnutritive sweetener(s) is added, in which the applicant has its principal the statement shall indicate the pres- place of business or to the United ence of both types of sweetener; e.g., States Court of Appeals for the District ‘‘Sweetened with nutritive sweetener(s) of Columbia Circuit. and nonnutritive sweetener(s).’’ (ii) If the claim is approved, the (c)‘‘Low calorie’’ foods. A product pur- Agency shall notify the applicant, in porting to be ‘‘low calorie’’ must com- writing, and shall also publish in the ply with the criteria set forth for such FEDERAL REGISTER a notice informing foods in § 381.460. the public that the implied nutrient (d) ‘‘Reduced calorie’’ foods and other content claim has been approved for comparative claims. A product pur- use. porting to be ‘‘reduced calorie’’ or otherwise containing fewer calories than a (Paperwork requirements were approved by reference food must comply with the the Office of Management and Budget under criteria set forth for such foods in control number 0583–0088.) § 387.460(b) (4) and (5). [58 FR 675, Jan. 6, 1993, as amended at 59 FR (e) ‘‘Label terms suggesting usefulness 45198, Sept. 1, 1994; 60 FR 217, Jan. 3, 1995] as low calorie or reduced calorie foods’’. (1) Except as provided in paragraphs §§ 381.470–381.479 [Reserved] (e)(2) and (e)(3) of this section, a product may be labeled with terms such as § 381.480 Label statements relating to ‘‘diet,’’ ‘‘dietetic,’’ ‘‘artificially sweet- usefulness in reducing or maintaining body weight. ened,’’ or ‘‘sweetened with nonnutritive sweetener’’ only if the claim is not (a) General requirements. Any product false or misleading, and the product is that purports to be or is represented labeled ‘‘low calorie’’ or ‘‘reduced cal- for special dietary use because of use- orie’’ or bears another comparative cal- fulness in reducing body weight shall orie claim in compliance with the ap- bear: plicable provisions in this subpart. (1) Nutrition labeling in conformity (2) Paragraph (e)(1) of this section with § 381.409 of this subpart, unless ex- shall not apply to any use of such empt under that section, and terms that is specifically authorized by (2) A conspicuous statement of the regulation governing a particular food, basis upon which the product claims to or, unless otherwise restricted by regu- be of special dietary usefulness. lation, to any use of the term ‘‘diet’’ (b) Nonnutritive ingredients. (1) Any that clearly shows that the product is product subject to paragraph (a) of this offered solely for a dietary use other section that achieves its special die- than regulating body weight, e.g., ‘‘for tary usefulness by use of a nonnutri- low sodium diets.’’ tive ingredient (i.e., one not utilized in (3) Paragraph (e)(1) of this section normal metabolism) shall bear on its shall not apply to any use of such label a statement that it contains a terms on a formulated meal replace- nonnutritive ingredient and the per- ment or other product that is rep- centage by weight of the nonnutritive resented to be of special dietary use as ingredient. a whole meal, pending the issuance of a

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regulation governing the use of such (iii) For purposes of this paragraph, terms on foods. calculation of the amount of pounds (f) ‘‘Sugar free’’ and ‘‘no added shall be based on the most recent 2- sugar’’. Criteria for the use of the year average of business activity. terms ‘‘sugar free’’ and ‘‘no added Where firms have been in business less sugar’’ are provided for in § 381.460(c). than 2 years or where products have been produced for less than 2 years, [58 FR 675, Jan. 6, 1993; 58 FR 43789, Aug. 18, reasonable estimates must indicate 1993, as amended at 58 FR 47628, Sept. 10, 1993; 60 FR 217, Jan. 3, 1995] that the annual pounds produced will not exceed the amounts specified. §§ 381.481–381.499 [Reserved] (2) Products intended for further processing, provided that the labels for § 381.500 Exemption from nutrition la- these products bear no nutrition claims beling. or nutrition information, (a) The following poultry products (3) Products that are not for sale to are exempt from nutrition labeling: consumers, provided that the labels for (1) Food products produced by small these products bear no nutrition claims businesses other than the major cuts of or nutrition information, single-ingredient, raw poultry products (4) Products in small packages that identified in § 381.444 produced by small are individually wrapped packages of businesses, provided that the labels for less than 1⁄2 ounce net weight, provided these products bear no nutrition claims that the labels for these products bear or nutrition information, and ground no nutrition claims or nutrition infor- or chopped products described in mation, § 381.401 produced by small businesses (5) Products custom slaughtered or that bear a statement of the lean per- prepared, centage and fat percentage on the label (6) Products intended for export, and or in labeling in accordance with (7) The following products prepared § 381.462(f), provided that labels or la- and served or sold at retail provided beling for these products bear no other that the labels or the labeling of these nutrition claims or nutrition informa- products bear no nutrition claims or tion, nutrition information: (i) A food product, for purposes of the (i) Ready-to-eat products that are small business exemption, is defined as packaged or portioned at a retail store a formulation, not including distinct or similar retail-type establishment, flavors which do not significantly alter provided, however, that this exemption the nutritional profile, sold in any size does not apply to ready-to-eat ground package in commerce. or chopped poultry products described (ii) For purposes of this paragraph, a in § 381.401 that are packaged or small business is any single-plant facil- portioned at a retail establishment, un- ity, including a single retail store, or less the establishment qualifies for an multi-plant company/firm, including a exemption under (a)(1); multi-retail store operation that em- (ii) Multi-ingredient products (e.g. ploys 500 or fewer people and produces sausage) processed at a retail store or no more than the following amounts of similar retail-type establishment, pro- pounds of the product qualifying the vided, however, that this exemption firm for exemption from this subpart: does not apply to multi-ingredient (A) During the first year of imple- ground or chopped poultry products de- mentation of nutrition labeling, from scribed in § 381.401 that are processed at July 1994 to July 1995, 250,000 pounds or a retail establishment, unless the es- less, tablishment qualifies for an exemption (B) During the second year of imple- under (a)(1); and mentation of nutrition labeling, from (iii) Products that are ground or July 1995 to July 1996, 175,000 pounds or chopped at an individual customer’s re- less, and quest. (C) During the third year of imple- (b) Restaurant menus generally do mentation and subsequent years there- not constitute labeling or fall within after, 100,000 pounds or less. the scope of these regulations.

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(c)(1) Foods represented to be specifi- have a total area available to bear la- cally for infants and children less than beling of 3 square inches or less may 2 years of age shall bear nutrition la- provide all required information in a beling as provided in paragraph (c)(2) of type size no smaller than 1⁄32-inch min- this section, except such labeling shall imum height. not include calories from fat, calories from saturated fat, saturated fat, ste- [58 FR 675, Jan. 6, 1993, as amended at 58 FR aric acid, polyunsaturated fat, 47628, Sept. 10, 1993; 59 FR 45198, Sept. 1, 1994; monounsaturated fat, and cholesterol. 60 FR 217, Jan. 3, 1995; 75 FR 82167, Dec. 29, 2010; 76 FR 76891, Dec. 9, 2011] (2) Foods represented or purported to be specifically for infants and children less than 4 years of age shall bear nu- Subpart Z—Selected Establish- trition labeling except that: ments; Cooperative Program (i) Such labeling shall not include for Interstate Shipment of declarations of percent of Daily Value Poultry Products for total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, and dietary fiber; SOURCE: 76 FR 24756, May 2, 2011, unless (ii) Nutrient names and quantitative otherwise noted. amounts by weight shall be presented § 381.511 Definitions. in two separate columns; (iii) The heading ‘‘Percent Daily Cooperative interstate shipment pro- Value’’ required in § 381.409(d)(6) shall gram. A cooperative poultry products be placed immediately below the quan- inspection program described in titative information by weight for pro- § 381.187 of this part. tein; Cooperative State poultry products in- (iv) The percent of the Daily Value spection program. A cooperative State- for protein, vitamins, and minerals Federal poultry products inspection shall be listed immediately below the program described in § 381.185 of this heading ‘‘Percent Daily Value’’; and part. (v) Such labeling shall not include Designated personnel. State inspection the footnote specified in § 381.409(d)(9). personnel that have been trained in the (d)(1) Products in packages that have enforcement of the Act and any addi- a total surface area available to bear tional State program requirements in labeling of less than 12 square inches order to provide inspection services to are exempt from nutrition labeling, selected establishments. provided that the labeling for these products bear no nutrition claims or Interstate commerce. ‘‘Interstate com- other nutrition information except merce’’ has the same meaning as that this exemption does not apply to ‘‘commerce’’ under § 381.1 of this part. the major cuts of single-ingredient, Selected establishment. An establish- raw poultry products identified in ment operating under a State coopera- § 381.444. The manufacturer, packer, or tive poultry products inspection pro- distributor shall provide, on the label gram that has been selected by the Ad- of packages that qualify for and use ministrator, in coordination with the this exemption, an address or tele- State where the establishment is lo- phone number that a consumer can use cated, to participate in a cooperative to obtain the required nutrition infor- interstate shipment program. mation (e.g., ‘‘For nutrition information call 1–800–123–4567’’). § 381.512 Purpose. (2) When such products bear nutri- This subpart Z prescribes the condition labeling, either voluntarily or be- tions under which States that admin- cause nutrition claims or other nutri- ister cooperative State poultry prod- tion information is provided, all re- ucts inspection programs and estab- quired information shall be in a type size no smaller than 6 point or all lishments that operate under such programs may participate in a cooperative upper case type of 1⁄16-inch minimum height, except that individual serving- interstate shipment program. size packages of poultry products that

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§ 381.513 Requirements for establish- the poultry products prepared by the ments; ineligible establishments. establishment. (a) An establishment that operates (7) The total number of employees under a cooperative State poultry can never exceed 35 individuals at any products inspection program may given time, regardless of the average apply to participate in a cooperative number of employees. interstate shipment program under (c) The following establishments are this subpart if: ineligible to participate in a coopera- (1) The establishment employs on av- tive interstate shipment program: erage no more than 25 employees based (1) Establishments that employ more on the standards described in para- than 25 employees on average (except graph (b) of this section, or as provided under paragraph (a)(2) of (2) The establishment employed more this section); than 25 employees but fewer than 35 (2) Establishments operating under a employees as of June 18, 2008. If se- Federal-State program as provided in lected to participate in a cooperative § 381.186 of this part as of June 18, 2008; interstate shipment program, an estab- (3) Official establishments; lishment under this paragraph must (4) Establishments that were official employ on average no more than 25 em- establishments as of June 18, 2008, but ployees as of July 1, 2014, or it must that were re-organized on a later date transition to become an official estab- by the person that controlled the es- lishment as provided in § 381.521 of this tablishment as of June 18, 2008; subpart. (5) Establishments operating under a (b) An establishment that has 25 or cooperative State poultry products in- fewer employees based on the following spection program that employed more standards is considered to have 25 or than 35 employees as of June 18, 2008, fewer employees on average for pur- that were reorganized on a later date poses of this subpart. by the person that controlled the es- (1) All individuals, both supervisory tablishment as of June 18, 2008; and non-supervisory, employed by the (6) Establishments that are the sub- establishment on a full-time, part- ject of a transition under § 381.521 of time, or temporary basis whose duties this subpart; involve handling the poultry products (7) Establishments that are in viola- prepared by the establishment are tion of the Act; counted when calculating the total (8) Establishments located in States number of employees. without a cooperative State poultry (2) All individuals employed by the products inspection program; and establishment from a temporary em- (9) Establishments located in a State ployee agency, professional employee whose agreement for a cooperative organization, or leasing concern whose interstate shipment program was ter- duties involve handling the poultry minated by the Administrator as pro- products prepared by the establishment vided in § 381.187(d) of this part. are counted when calculating the total (d) An establishment that meets the number of employees. conditions in paragraph (a) of this sec- (3) The average number of employees tion and that is not an ineligible estab- is calculated for each of the pay peri- lishment under paragraph (c) of this ods for the preceding 12 calendar section may apply for selection into a months. cooperative interstate shipment pro- (4) Part-time and temporary employ- gram through the State in which the ees are counted the same as full-time establishment is located. employees. [76 FR 24756, May 2, 2011, as amended at 76 (5) If the establishment has not been FR 81360, Dec. 28, 2011] in business for 12 months, the average number of employees is calculated for § 381.514 State request for cooperative each of the pay periods in which the es- agreement. tablishment has been in business. (a) State participation in a coopera- (6) Volunteers who receive no com- tive interstate shipment program pensation are not considered employees under this subpart is limited to States unless their duties involve handling that have implemented cooperative

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State poultry products inspection program as provided in paragraph (c) of grams. this section, the Administrator will: (b) To request an agreement for a co- (1) Appoint an FSIS employee as the operative interstate shipment program FSIS selected establishment coordi- under this subpart, a State must sub- nator for the State and mit a written request to the Adminis- (2) Coordinate with the State to se- trator through the FSIS District Office lect establishments to participate in for the FSIS District in which the the program as provided in § 381.515(b) State is located. In the request the of this subpart. State must: (1) Identify establishments in the § 381.515 Establishment selection; offi- State that have requested to be se- cial number for selected establish- lected for the program that the State ments. recommends for initial selection into (a) An establishment operating under the program, if any; a cooperative State poultry products (2) Demonstrate that the State is inspection program will qualify for se- able to provide the necessary inspec- lection into a cooperative interstate tion services to selected establish- shipment program if the establishments in the State and conduct any re- ment: lated activities that would be required (1) Has submitted a request to the under a cooperative interstate ship- State to be selected for the program; ment program established under this subpart; and (2) Has the appropriate number of (3) Agree that, if the State enters employees under § 381.513(a) of this sub- into an agreement with FSIS for a co- part; operative interstate shipment program, (3) Is not ineligible to participate in the State will: a cooperative interstate shipment pro- (i) Provide FSIS with access to the gram under § 381.513(c) of this subpart; results of all laboratory analyses con- (4) Is in compliance with all require- ducted on product samples from se- ments under the cooperative State lected establishments in the State; poultry products inspection program; (ii) Notify the selected establishment and coordinator for the State of the results (5) Is in compliance with all require- of any laboratory analyses that indi- ments under the Act and the imple- cate that a product prepared in a se- menting regulations in this chapter. lected establishment may be adulter- (b) To participate in a cooperative ated or may otherwise present a food interstate shipment program, an estab- safety concern; and lishment that meets the conditions in (iii) When necessary, cooperate with paragraph (a) of this section must be FSIS to transition selected establish- selected by the Administrator, in co- ments in the State that have been ordination with the State where the es- deselected from a cooperative inter- tablishment is located. state shipment program to become offi- (c) If an establishment is selected to cial establishments. participate in a cooperative interstate (c) If the Administrator determines shipment program as provided in para- that a State that has submitted a re- graph (b) of this section, the State is to quest to participate in a cooperative assign the establishment an official interstate shipment program qualifies number that reflects the establish- to enter into a cooperative agreement ment’s participation in the cooperative for such a program, the Administrator interstate shipment program and ad- and the State will sign a cooperative vise the FSIS selected establishment agreement that sets forth the terms coordinator for the State of the official and conditions under which each party number assigned to each selected es- will cooperate to provide inspection tablishment in the State. The official services to selected establishments lo- numbers assigned to every selected es- cated in the State. tablishment must contain a suffix, e.g., (d) After the Administrator and a ‘‘SE,’’ that identifies the establishment State have signed an agreement for a as a selected establishment; that in- cooperative interstate shipment pro- cludes the letter ‘‘P,’’ which identifies

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the establishment as a poultry estab- ment’s schedule of operations, and the lishment; and that identifies the State, establishment’s performance under the e.g., ‘‘SEPND,’’ for ‘‘selected establish- cooperative interstate shipment pro- ment poultry North Dakota.’’ gram. If necessary, the selected estab- (d) Failure of a State to comply with lishment coordinator, in consultation paragraph (c) of this section will dis- with the District Manager that covers qualify the State from participation in the State, may designate qualified the cooperative interstate shipment FSIS personnel to visit a selected es- program. tablishment on behalf of the selected § 381.516 Commencement of a coopera- establishment coordinator. tive interstate shipment program; (b) The selected establishment coor- inspection by designated personnel dinator, in coordination with the and official mark. State, will verify that selected estab- (a) A cooperative interstate shipment lishments in the State are receiving program will commence when the Ad- the necessary inspection services from ministrator, in coordination with the designated personnel, and that these State, has selected establishments in establishments are eligible, and remain the State to participate in the pro- eligible, to participate in a cooperative gram. interstate shipment program. The se- (b) Inspection services for selected lected establishment coordinator’s establishments participating in a coop- verification activities may include: erative interstate shipment program (1) Verifying that each selected es- must be provided by designated per- tablishment employs, and continues to sonnel, who will be under the direct su- employ, 25 or fewer employees, on aver- pervision of a State employee. age, as required under § 381.513(a) of (c) Poultry products processed in a this part, unless the establishment is selected establishment and inspected transitioning to become an official es- and passed by designated State personnel must bear an official Federal tablishment; mark, stamp, tag, or label of inspection (2) Verifying that the designated per- in the appropriate form prescribed in sonnel are providing inspection serv- subpart M of this part that includes ices to selected establishments in a the information specified in § 381.515(c) manner that complies with the Act and of this subpart. the implementing regulations in this (d) Poultry products processed in a chapter; selected establishment that comply (3) Verifying that that the State with the conditions in paragraph (c) of staffing levels for each selected estab- this section may be distributed in lishments are appropriate to carry out interstate commerce. the required inspection activities; and (4) Assessing each selected establish- § 381.517 Federal oversight of a cooperative interstate shipment pro- ment’s compliance with the Act and gram. implementing regulations in this chapter. (a) The FSIS selected establishment coordinator for a State that has en- (c) If the selected establishment co- tered into an agreement for a coopera- ordinator determines that designated tive interstate shipment program will personnel are providing inspection visit each selected establishment in services to selected establishments in the State on a regular basis to verify the State in a manner that is incon- that the establishment is operating in sistent with the Acts and the imple- a manner that is consistent with the menting regulations in this chapter, Act and the implementing regulations the Administrator will provide an op- in this chapter. The frequency with portunity for the State to develop and which the SEC will visit selected estab- implement a corrective action plan to lishments under the SEC’s jurisdiction address inspection deficiencies identi- will be based on factors that include, fied by the selected establishment co- but are not limited to, the complexity ordinator. If the State fails to develop of the operations conducted at the se- a corrective action plan, or the selected establishment, the establish- lected establishment coordinator for

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the State determines that the correc- this chapter. Selected establishments tive action plan is inadequate, the Ad- participating in a cooperative inter- ministrator will terminate the agree- state shipment program are subject to ment for the cooperative interstate the notification and appeal procedures shipment program as provided in set out in part 500 of this chapter. § 381.187(d) of this part. (c) If inspection at a selected establishment is suspended for any of the § 381.518 Quarterly reports. reasons specified in § 500.3 or § 500.4 of (a) The selected establishment coor- this chapter, FSIS will: dinator will prepare a report on a quar- (1) Provide an opportunity for the es- terly basis that describes the status of tablishment to implement corrective each selected establishment under his actions and remain in the cooperative or her jurisdiction. interstate shipment program, or (b) The quarterly report required in (2) Move to deselect the establish- paragraph (a) of this section will: ment as provided in § 381.520 of this sub- (1) Include the selected establish- part. ment coordinator’s assessment of the (d) The decision to deselect a selected performance of the designated per- establishment under a suspension will sonnel in conducting inspection activi- be made on a case-by-case basis. In ties at selected establishments and making this decision, FSIS, in con- (2) Identify those selected establish- sultation with the State where the se- ment that the selected establishment lected establishment is located, will coordinator has verified are in compli- consider, among other factors: ance with the Act and implementing (1) The non-compliance that led to regulations in this chapter, those that the suspension; have been deselected under § 381.520 of (2) The selected establishment’s com- this subpart, and those that are pliance history; and transitioning to become official estab- (3) The corrective actions proposed lishments under § 381.521 of this sub- by the selected establishment. part. (c) The selected establishment coor- § 381.520 Deselection of ineligible es- dinator is to submit the quarterly re- tablishments. port to the Administrator through the (a) The Administrator will deselect a District Manager for the State where selected establishment that becomes the selected establishments identified ineligible to participate in a coopera- in the report are located. tive interstate shipment program for any reason listed under § 381.513(c) of § 381.519 Enforcement authority. this subpart. (a) To facilitate oversight and en- (b) An establishment that has been forcement of this subpart, selected es- deselected must transition to become tablishments operating under a cooper- an official establishment as provided in ative interstate shipment program § 381.521 of this subpart. must, upon request, give the FSIS selected establishment coordinator or § 381.521 Transition to official estab- other FSIS officials access to all establishment. lishment records required under the (a) If an establishment is deselected Act and the implementing regulations from a cooperative interstate shipment in this chapter. The Administrator program as provided in § 381.520 of this may deselect any selected establish- subpart, FSIS, in coordination with the ment that refuses to comply with this State where the establishment is lo- paragraph. cated, will develop and implement a (b) Selected establishment coordina- plan to transition the establishment to tors may initiate any appropriate en- become an official establishment. Ex- forcement action provided for in part cept that an establishment that was 500 of this chapter if they determine deselected from a cooperative inter- that a selected establishment under state shipment program because it is their jurisdiction is operating in man- located in a State whose agreement for ner that is inconsistent with the Act such a program was terminated may ei- and the implementing regulations in ther transition to become an official

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establishment or transition to become receives a transition grant must use a State-inspected establishment under grant funds to reimburse the training the cooperative State poultry products costs of one employee per each selected inspection program. establishment in the State. Any other (b) An establishment that has been use of such funds is prohibited. deselected from a cooperative interstate shipment program and success- § 381.523 Separation of operations. fully transitioned to become an official establishment may withdraw from the A selected establishment may con- Federal inspection program and resume duct operations under the cooperative operations under the cooperative State State poultry products inspection pro- poultry products inspection program gram if the establishment implements after operating as an official establish- and maintains written procedures for ment in full compliance with the Act complete physical separation of prod- for a year. uct and process for each operation by time or space. § 381.522 Transition grants. (a) Transition grants are funds that a § 381.524 Voluntary withdrawal. State participating in a cooperative A selected establishment that is in interstate shipment program under full compliance with the requirements this subpart may apply for to reim- in this part may voluntarily end its burse selected establishments in the participation in a cooperative inter- State for the cost to train one indi- state shipment program and operate vidual in the seven HACCP principles under the cooperative State poultry for meat or poultry processing as re- products inspection program. Estab- quired under § 417.7 of this chapter and lishments that voluntarily end their associated training in the development of sanitation standard operating proce- participation in the cooperative may dures required under part 416 of this re-apply for the program after oper- chapter. ating under the cooperative State poul- (b) A State participating in a cooper- try products inspection program for ative interstate shipment program that one year.

SUBCHAPTERS B–C [RESERVED]

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